[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyotrophic-lateral-sclerosis-als\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyotrophic-lateral-sclerosis-als":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,51,0,25,[9,43,76,99,123,149,174,200,226,253,285,304,327,363,393,414,439,459,478,496,521,542,571,616,644],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":7},"100605398","phase-2-study-of-coya-302-for-the-treatment-of-als-100605398",false,"NCT07161999","Study of COYA 302 for the Treatment of ALS","Phase 2\u002F3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study With Additional 24-Week Blinded Active Extension to Evaluate the Safety and Efficacy of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)","ALSTARS","Key Inclusion Criteria:\n\n1. Sporadic or familial ALS, diagnosed as clinically probable, lab-supported probable, or definite ALS according to the revised El Escorial criteria\n2. Male or female participants aged 18 to 80\n3. Time since onset of ALS symptoms ≤28 months from Screening.\n4. ALSFRS-R total score ≥35 at Screening\n5. Rate of progression at baseline between -0.5 and -1.5 points per month on ALSFRS-R total score.\n6. SVC ≥60% of predicted capacity.\n7. Participants receiving riluzole must be on a stable dose for at least 30 days prior to Screening, with intent to stay on stable dosage throughout the study. If not on a stable dose of riluzole for at least 30 days prior to Screening, willing to refrain from initiation of the agent for the duration of the trial.\n8. Participants receiving edaravone (intravenous \\[IV\\] or oral, RADICAVA®) must have completed at least one treatment cycle prior to Screening, with intent to remain on stable dosage throughout the study. If participant has not completed at least one treatment cycle of edaravone at the time of Screening, willing to refrain from initiation of the agent for the duration of the trial.\n9. Participants receiving tofersen (QALSODY®) must have completed 90 days of treatment prior to Screening, with intent to remain on stable dosage throughout the study. If participant has not completed at least 90 days of tofersen at the time of Screening, willing to refrain from initiation of the agent for the duration of the trial.\n\nKey Exclusion Criteria:\n\n1. Any clinically significant and\u002For unstable medical (including active systemic infections requiring treatment), surgical, or psychiatric condition or laboratory abnormality other than ALS, in the judgement of the Investigator.\n2. Active suicidality (e.g., any suicide attempts within the past 12 months or any current suicidal intent, including a plan, as assessed by the C-SSRS, score of \"YES\" on questions 4 or 5; and\u002For based on clinical evaluation by the Investigator).\n3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal (ULN).\n4. Significant renal impairment as determined by estimated glomerular filtration rate (eGFR) of \\\u003C60 mL\u002Fmin.\n5. Pre-existing chronic obstructive pulmonary disease or significant pulmonary impairment including those with an FEV1 ≤ 2 liters or \\\u003C 75% predicted for height and age, in the judgement of the Investigator.\n6. Clinically significant history of cardiac function impairment including cardiac ejection fraction below 40%, ventricular wall motion abnormalities, or coronary artery disease.\n7. Any organ allografts.\n8. A positive tuberculosis (TB) test indicating a latent TB infection or a positive test for viral hepatitis.\n9. Currently receiving or have received abatacept treatment within 75 days prior to Screening.\n10. Currently receiving or have received interleukin-2 (IL-2) treatment within 30 days prior to Screening.\n11. Currently receiving or expected to receive immunosuppressant therapy (e.g., cyclosporine, sirolimus, tacrolimus, mycophenolate mofetil, systemic steroids) over the course of the study.\n12. Planning to receive a live vaccine during the study or within 3 months of discontinuation.\n13. Current participation in another interventional clinical trial and\u002For participation in any investigational medication or device clinical trial within 30 days prior to Screening or 5 half-lives of elimination of the investigational medication, whichever is longer.\n14. Previous participation in any COYA 302 (LD rhIL-2 and DRL\\_AB) study.\n15. Uncontrolled autoimmune condition.\n16. Presence of an indwelling central catheter.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","80 Years",{"count":22,"type":23},120,"ESTIMATED","INTERVENTIONAL",[26,27],"PHASE2","PHASE3","The ALSTARS trial will be conducted across 20-25 sites in the US and Canada, and will evaluate the safety and efficacy of an investigational treatment called COYA 302 for adults with Amyotrophic Lateral Sclerosis (ALS).\n\nCOYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. It is comprised of low dose interleukin-2 (LD IL-2) and DRL\\_AB (a biosimilar candidate for abatacept). Participants will be randomly assigned to receive one of 2 regimens of COYA 302 or placebo (an inactive substance) in a 1:1:1 ratio for 24 weeks in the double-blind (DB) period. Those who complete this part of the study will be eligible to receive one of the two regimens of COYA 302 for an additional 24 weeks in a blinded active extension phase (EXT).\n\nThe study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments. Additional objectives include evaluation of biomarkers and safety through routine clinical assessments and adverse event monitoring.",[30],"Amyotrophic Lateral Sclerosis (ALS)","RECRUITING","2026-08-04",{"date":34,"type":35},"2026-08-06","ACTUAL",{"date":37,"type":35},"2025-10-01",{"date":39,"type":23},"2027-07",{"name":41,"class":42},"Coya Therapeutics","INDUSTRY",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100612724","lung-insufflation-capacity-training-and-respiratory-function-in-amyotrophic-lateral-sclerosis-100612724","NCT07257302","Lung Insufflation Capacity Training and Respiratory Function in Amyotrophic Lateral Sclerosis","Exploratory Study on the Effects of Lung Insufflation Capacity Training Using the LIC Trainer in Patients With Amyotrophic Lateral Sclerosis: A Single-Center Prospective Interventional Study","LIC-ALS","Inclusion Criteria:\n\n* Age 20 years or older\n* Diagnosis of amyotrophic lateral sclerosis (ALS) according to the El Escorial or Awaji criteria\n* Not using noninvasive ventilation (NIV) and without tracheostomy at the start of LIC training\n* Able to perform study assessments and provide written informed consent (or assisted signature with communication aid)\n\nExclusion Criteria:\n\n* Chronic pulmonary disease other than ALS (e.g., COPD, interstitial lung disease)\n* Severe cognitive or communication impairment preventing study participation\n* Uncontrolled cardiovascular disease, including unstable angina, recent myocardial infarction, decompensated heart failure, serious arrhythmia, severe aortic stenosis, or active myocarditis\u002Fendocarditis\n* Uncontrolled hypertension\n* Acute systemic illness or fever\n* Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension\n* Severe hepatic or renal dysfunction\n* Any condition judged inappropriate by the investigator","20 Years",{"count":7,"type":23},[54],"NA","The goal of this clinical trial is to determine whether lung insufflation capacity (LIC) training can help maintain respiratory function and prolong tracheostomy-free survival in people with amyotrophic lateral sclerosis (ALS).\n\nThe main questions are:\n\nDoes early and continuous LIC training slow the decline in forced vital capacity (FVC)? Does LIC training prolong the time to tracheostomy or death?\n\nThis single-center study at the National Center of Neurology and Psychiatry (NCNP) in Japan will enroll 25 adults with ALS diagnosed according to the El Escorial or Awaji criteria. This is a single-arm study with no concurrently enrolled control group. Comparative analyses will use matched external controls. PRO-ACT will be used primarily to evaluate short-term respiratory-function trajectories, while JACALS, if data access is approved, will be used primarily to evaluate long-term time-to-event outcomes.\n\nParticipants will:\n\n* Use the LIC Trainer device to perform lung insufflation training twice daily at home\n* Visit the clinic every 3 months for respiratory and functional assessments\n* Undergo respiratory tests, including FVC, LIC, maximum insufflation capacity (MIC), and cough peak flow (CPF)\n* Complete the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)",[30],[58,59,60,61,62,63,64],"LIC Trainer","lung volume recruitment","respiratory rehabilitation","FVC","ALS","ALSFRS-R","cough peak flow","2026-07-29",{"date":67,"type":35},"2026-07-30",{"date":69,"type":35},"2025-11-01",{"date":71,"type":23},"2030-03-31",{"name":73,"class":74},"National Center of Neurology and Psychiatry, Japan","OTHER",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100570215","phase-1-safety-study-of-xt-150-in-participants-with-als-100570215","NCT06704347","Safety Study of XT-150 in Participants With ALS","A Phase 1, Open-Label Study Assessing the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Single Ascending Dose Regimens of XT-150 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)","Key Inclusion Criteria:\n\n* Adults between 18 and 80 years of age\n* Male or female, if of childbearing potential or sexually active, strict contraception required\n* Have ALS diagnosed by a doctor (specifically, sporadic or familial ALS diagnosed as clinically probable, lab-supported probable or definite ALS defined by the El Escorial criteria)\n* Have had symptoms of ALS (muscle weakness) within 36 months of starting this study\n* Have the ability to slowly exhale a volume of air at least 60% of what is expected for the participant's sex, height and age\n* Have not received treatment for ALS or are currently on a stable dose of an approved treatment for ALS. Patients currently receiving Tofersen are not eligible.\n* Able to receive the study injection intrathecally, determined by the study doctor\n* Able to undergo the study procedures and adhere to the study visit schedule at the time of study entry, with an estimated life expectancy of 6 months or greater\n\nKey Exclusion Criteria:\n\n* Have an implanted shunt to drain cerebrospinal fluid (CSF) or an implanted CNS catheter\n* Have an implanted of diaphragm pacing system\n* Tracheostomy\n* History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study\n* History or current diagnosis of respiratory conditions such as COPD\n* History or current diagnosis of cancer, chemical meningitis, HIV, Hep B, Hep C, uncontrolled diabetes\n* Presence of an autoimmune condition (for example, rheumatoid arthritis or lupus) requiring treatment or immunodeficiency\n* Clinical or laboratory evidence of hepatic or renal disease\u002Finjury.\n* Taking any prohibited medications\n* Women who are pregnant or nursing\n* Use of any investigational drugs or devices within 30 days or 5 half-lives of the study agent (whichever is longer). Exception: Observational, non-interventional clinical studies are allowed in the opinion of the study doctor.\n* Any other condition that the study doctor feels could compromise the participant's safety, ability to communicate with the study staff, or the quality of the data",{"count":84,"type":23},8,[86],"PHASE1","This is a Phase 1, open-label, multi-center safety study of XT-150 in adult participants with Amyotrophic Lateral Sclerosis (ALS).\n\nParticipants providing informed consent and meeting all study eligibility criteria will be enrolled in the study and will receive a single injection of XT-150 at the Baseline visit. Follow-up visits will occur over 180 days (6 months) after the injection.\n\n8 participants (4 participants per dose level) will be enrolled sequentially in up to 2 ascending, single dose cohorts: Cohort 1: 1.5 mg XT-150 Cohort 2: 4.5 mg XT-150",[30],"NOT_YET_RECRUITING","2026-07-28",{"date":65,"type":35},{"date":93,"type":23},"2027-03",{"date":95,"type":23},"2028-06",{"name":97,"class":42},"Xalud Therapeutics, Inc.",4,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":103,"conditions":110,"keywords":111,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100594775","phase-2-usnoflast-neuromuscular-investigation-for-treatment-efficacy-in-amyotrophic-lateral-sclerosis-100594775","NCT07023835","Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis","A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS","UNITE-ALS","Inclusion Criteria:\n\n* Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology criteria\n* Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis symptom onset. For the purposes of this study, the date of symptom onset will be defined as the date the subject first had symptoms of their disease, i.e., limb weakness, dysarthria, dysphagia, shortness of breath, or fasciculations, from the screening visit.\n* Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised score of ≥35 at screening.\n* Slow vital capacity: ≥60% of predicted capacity at the screening visit.\n* Be able to swallow capsules.\n* Either not currently receiving riluzole\u002Fsodium phenylbutyrate and taurursodiol\u002Ftofersen or on a stable dose of riluzole\u002Fsodium phenylbutyrate and taurursodiol\u002Ftofersen for at least 4 weeks before the screening visit. Subjects receiving riluzole\u002Fsodium phenylbutyrate and taurursodiol\u002Ftofersen are expected to remain on the same dose throughout the duration of the study.\n* Either not currently receiving edaravone or on edaravone treatment. Subjects receiving edaravone must have completed at least 1 cycle of treatment before the screening visit and are expected to continue with a stable dose of edaravone treatment throughout the duration of the study.\n* Capable of providing informed consent and complying with study procedures in the opinion of the investigator\n\nExclusion Criteria:\n\n* Presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse that would impair the ability of the subject to provide informed consent, in the opinion of the investigator.\n* Serious illness (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the judgment of the investigator.\n* Active herpes zoster infection within 2 months prior to the screening visit.\n* Any medical condition that promotes suicidal attempt or behavior within 6 months prior to the screening visit and in the opinion of the investigator might interfere with subject's participation in the study or is a risk for a suicide attempt.\n* History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or active cancer or another medically significant illness other than Amyotrophic lateral sclerosis, precluding safe participation of subject in this study in the opinion of the investigator.\n* Known allergy, sensitivity, or intolerance to Investigational product or excipients.\n* Subjects who have taken concomitant medications that are substrates of drug metaboliz-ing enzymes (Cytochrome P450 1A2 and\u002For Cytochrome P450 2B6) within 7 days or 5 half-lives of the medication (whichever is longer) before the first dose of Investigational product and throughout the study.\n* Use of any steroids, colchicine, or anti-IL-1 inhibitors within 7 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of Investigational product administration.\n* Use of any investigational drug concurrently or within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of Investigational product administration.\n* Any clinically significant condition and\u002For laboratory significant value that would prevent the subject from participating in the study in the opinion of the investigator.\n* Received a live vaccine within 14 days before the screening visit or planning to receive during the study duration.\n* Subjects who have received stem cell or gene therapy for Amyotrophic lateral sclerosis at any time in the past.\n* Following laboratory test values at screening:\n\n  1. Alanine aminotransferase or Aspartate aminotransferase values \\>3.0 × Upper Limit of Normal\n  2. Bilirubin \\>1.5 × Upper Limit of Normal unless the subject has documented Gilbert's syndrome (isolated bilirubin \\>1.5 × Upper Limit of Normal is acceptable if bilirubin is fractionated, and direct bilirubin is \\\u003C35%)\n  3. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2\n* For those participating in the optional Cerebrospinal fluid collection, contraindications to lumbar puncture including but not limited to lumbar scoliosis, coagulopathy, infection at site of puncture, or use of anticoagulants.\n* Subjects with history of epilepsy within 6 months of screening visit.\n* Surgery within last 3 months or planned major surgery within next 3 months from the date of screening (other than minor cosmetic surgery and minor dental surgery).\n* Use or intended use of any medications\u002Fproducts known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 4 weeks of screening and up to end of study. Use of such medication will be considered on a case-by-case basis as per the opinion of the investigator and\u002For independent medical monitor.\n* Receiving an elemental diet or parenteral nutrition.\n* Received blood transfusion within 3 months prior to screening.\n* Subjects with Human immunodeficiency virus, hepatitis B, hepatitis C, coronary artery disease, or active gastrointestinal condition that might interfere with drug absorption.\n* Inability to be venipunctured or those not able to tolerate venous puncture.\n* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of employees of investigator or the investigator.\n* Any condition not mentioned in any of above criteria that, as per the investigator, would hinder participation of the subject in the study. This may include, but not limited to, considerations of safety, compliance, or other factors that could impact the integrity of the study or the well-being of the subject.\n* If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of Investigational product. If male of reproductive capacity, unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of Investigational product.\n\nFor Open Label Extension\n\nInclusion Criteria:\n\n* Completion in the randomized, double blind Usnoflast study (main study).\n* Subjects who elect to continue treatment after completion of Usnoflast phase 2b study must enrol in the OLE within 28 days of the completion of Week 36 visit of the main study.\n* Provide a new informed consent to enter the OLE phase.\n\nExclusion Criteria:\n\n* Discontinued IP prematurely in the double-blind phase of the study for reasons other than tracheostomy or permanent-assisted ventilation.\n* Treatment with or use of any restricted medications.\n* Any ongoing AE that, in the opinion of the site investigator, is clear contraindication to the IP.\n* Unstable cardiac or other life-threatening disease emergent during the randomized, double-blind study\n* Any major medical history or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the investigator, unsuitable for the study.\n* If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of IP. If male of reproductive capacity, unwilling to use effective contraception during the study and for at least 1 month after administration of last dose of IP.",{"count":108,"type":23},240,[26],[30],[112,62,113],"Amyotrophic Lateral Sclerosis,","Usnoflast","2026-07-24",{"date":90,"type":35},{"date":117,"type":35},"2025-09-17",{"date":119,"type":23},"2028-10",{"name":121,"class":42},"Zydus Therapeutics Inc.",17,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":24,"phases":132,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":75},"100648801","plasmapheresis-in-amyotrophic-lateral-sclerosis-with-autoantibody-against-nrip-2-paladin2-100648801","NCT07726563","Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP 2 (PALADIN2)","PALADIN2","Inclusion Criteria:\n\n* ALS patients above 20-year-old who have anti-NRIP autoantibody in plasma\n* Agree to receive plasmapheresis treatment\n* Agree to participate in the study and receive serial examinations\n\nExclusion Criteria:\n\n* Under permanent ventilator support\n* Cannot receive plasmapheresis treatment or serial examinations\n* Under pregnancy\n* Blood fibrinogen level below 50 mg\u002Fdl\n* Belong to special subtype of ALS, such as primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, flail leg syndrome.",{"count":131,"type":23},20,[54],"10-20% of patients with ALS have anti-NRIP autoantibody and the titer of anti-NRIP autoantibody is correlated with motor functional decline and mortality in ALS. The PALADIN2 clinical trial is a single arm study, which intends to enroll 20 ALS patients having anti-NRIP autoantibody in plasma. Patients will receive 3 courses of plasmapheresis per 3 months in order to maintain low concentration of anti-NRIP autoantibody in plasma. The study will follow up these patients for another 6 months after plasmapheresis. This project will potentially confirm the efficacy and safety of plasmapheresis for ALS patients having anti-NRIP autoantibody.",[30,135,136],"Autoantibody","Plasmapheresis",[138,139,140],"amyotrophic lateral sclerosis","anti-NRIP autoantibody","plasmapheresis","2026-07-21",{"date":114,"type":35},{"date":144,"type":35},"2026-05-19",{"date":146,"type":23},"2029-07-31",{"name":148,"class":74},"National Taiwan University Hospital",{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100603882","phase-2-phenogene-1a-cromolyn-treatment-in-patients-with-mild-to-moderate-als-100603882","NCT07142291","PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS","A Phase IIB Randomized, Double-Blind, Placebo-Controlled, Multi-Dose Study to Evaluate the Effects of PHENOGENE-1A (Cromolyn) as an Adjuvant Treatment in Subjects With Mild to Moderate Amyotrophic Lateral Sclerosis (ALS)","Inclusion Criteria:\n\n1. Diagnosis of ALS; the diagnosis of ALS defined by revised El Escorial criteria as follows:\n\n   1. Evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological, or neuropathological examination.\n   2. Evidence of upper motor neuron (UMN) degeneration by clinical examination.\n   3. Progressive spread of symptoms or signs within a region or to other regions, as determined by clinical examination or the history of disease progression.\n   4. Absence of electrophysiological, neuroimaging, or pathological evidence of other diseases that might explain the UMN or LMN degeneration and exclusion of other causes.\n2. Male or female subjects aged 18 to 75 years inclusive.\n3. Must provide written informed consent for study-related procedures.\n4. Must be capable of completing all study-related procedures, assessments, and visits in the judgment of Investigator.\n5. Disease duration from ALS symptom onset of motor weakness ≤24 months.\n6. ALSFRS-R total score ≥38 at screening visit.\n7. ALSFRS-R Breathing subscore should be ≥9 at the time of screening.\n8. ALSFRS-R Bulbar subscore should be ≥9 at the time of screening.\n9. Forced vital capacity \\>70% of predicted value.\n10. PIFR ≥100 L\u002Fminute.\n11. Must be receiving a stable dose of standard-of-care treatment Riluzole for 4-weeks before signing informed consent.\n12. Female subjects who are of childbearing potential must agree to use of highly effective methods of contraception consistent with local regulations during the study, and for 3 months after the study drug administration. Examples include the following, but not limited to:\n\n    1. Combined (estrogen and progestogen containing) or progestogen-only hormonal contraceptives;\n    2. Intrauterine device or intrauterine hormone-releasing system; OR\n    3. Post-menopausal status must have experienced their last menstrual period minimum of 1 year prior to study drug administration; OR\n    4. Surgically sterilized. Female subject should be willing to not donate egg during the trial and for 3 months after the last dose of the study drug.\n13. Male subjects who are sexually active with a female of childbearing potential must agree to use highly effective contraception as described above, or a combination of 2 acceptable methods of contraception (e.g., a barrier method along with a female partner using a hormonal contraceptive method), in accordance with local regulations, throughout the duration of the study, and for 3 months after the last dose of the study drug.\n\n(Male subject should be willing to not donate sperm during the trial and for 3 months after the last dose of the study drug.)\n\nExclusion Criteria:\n\n1. ALSFRS-R score change (decrease) by 2.5 or more points between the screening visit and Day 1 (baseline) score.\n2. Bulbar onset ALS (\\\u003C9 bulbar subscore)\n3. Any use of non-invasive ventilation (e.g., continuous positive airway pressure, non-invasive bi-level positive airway pressure or non-invasive volume ventilation) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.\n4. Any other significant neurological disorder which can interfere with study assessments, e.g., significant cognitive impairment and\u002For clinical dementia.\n5. Significant psychiatric illness like schizophrenia, bipolar disorder etc. Subjects with depression can be included, only if the depression has been stable and no episode of major depression has occurred in the past year.\n6. Severe cardiac disease (e.g., QTc\\>500 ms), Torsade de Pointes, evidence of significant heart failure (New York Heart Association \\[NYHA\\] Class 3 or greater, myocardial infarction or unstable angina in the 6 months prior to screening).\n7. Any moderate-to-severe pulmonary disease or difficulty taking inhaled drugs.\n8. Inability to tolerate the administration of an oral inhaled powder via DPI.\n9. Has taken any investigational product within 30 days or 5 half lives of the drug, whichever is longer, prior to dosing.\n10. Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone, etc).\n11. Subjects with a body weight of 32 kg or less, or a body mass index of \\\u003C17.5 or \\>35.0 at time of screening.\n12. Moderate-to-severe liver disease: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\>3 times the upper limit of normal; total bilirubin \\> 1.5 x ULN.; subjects with hepatic diseases such as hepatic cirrhosis, hepatic cancer and active hepatitis.\n13. Moderate-to-severe renal disease: creatinine clearance \\\u003C45 mL\u002Fmin\u002F1.73 m2 (by Cockcroft-Gault calculation).\n14. Any clinically significant disorder or laboratory abnormality that, in the Investigator's opinion, could interfere with the subject's participation in the study, place the subject at increased risk, or confound interpretation of the study results.\n15. Pregnant or breast-feeding females.","75 Years",{"count":158,"type":23},105,[26],"The purpose of this study is to test the effects of PHENOGENE-1A, which is the treatment under investigation in this study. This research will investigate if PHENOGENE-1A can help people with ALS by measuring their function using the ALS Functional Rating Scale Revised (ALSFRS-R), measuring lung function using pulmonary function tests (PFTs), such as forced vital capacity (FVC), and measuring neuro-inflammatory biomarkers in the blood.",[30],[163,164,62],"Amyotrophic Lateral Sclerosis","Lou Gehrigs Disease",{"date":166,"type":35},"2026-07-23",{"date":168,"type":35},"2025-11-25",{"date":170,"type":23},"2027-06",{"name":172,"class":42},"PhenoNet, Inc.",22,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":24,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":131},"100543109","phase-1-first-in-human-fih-study-of-aln-sod-in-adult-participants-with-amyotrophic-lateral-sclerosis-associated-with-mutation-in-the-sod1-gene-sod1-als-100543109","NCT06351592","First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)","First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ALN-SOD in Participants With Amyotrophic Lateral Sclerosis and SOD1 Mutations","GOALS","Key Inclusion Criteria:\n\n1. Weakness attributable to ALS and a SOD1 variant that has been previously described as associated with ALS or is considered likely to cause ALS, as defined in the protocol\n2. Slow Vital Capacity (SVC) ≥50% predicted value based on age, gender and height, measured in upright position\n3. Body Mass Index (BMI) ≤35 kg\u002Fm2 at time of screening\n4. If participants are taking riluzole or edaravone, they must be on a stable dose for at least 4 weeks prior to initial dosing visit and are expected to remain at that dose until the end of the study\n5. Platelet count \\>50,000\u002Fmicroliter\n6. Has normal blood pressure readings, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Concurrent participation in another interventional clinical trial\n2. Has had a tracheostomy\n3. Has dementia, as assessed by the investigator\n4. Has uncontrolled psychiatric disease, including psychosis, active or recent suicidal ideation, untreated major depression, in the past 30 days\n5. Has a medical history of brain or spinal disease\u002Finjury that would interfere with the Lumbar Puncture (LP) process, CSF circulation or safety assessment, as defined in the protocol\n6. Presence of an implanted shunt for the drainage of CSF or an implanted Central Nervous System (CNS) catheter\n7. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study\n8. Was hospitalized (ie, \\>24 hours) for any reason other than ALS within 30 days of screening\n9. Has received treatment with tofersen within 6 months prior to screening\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply",{"count":183,"type":23},54,[86,26],"This study is researching an experimental drug called ALN-SOD (called \"study drug\"). This study is focused on people with Amyotrophic Lateral Sclerosis (ALS) caused by a change in a gene called the Superoxide Dismutase-1 (SOD1) gene. This type of ALS is known as \"SOD1-ALS\". This is the first time that ALN-SOD will be given to people.\n\nThe aim of the study is to see how safe and tolerable the study drug is.\n\nThe study is looking at several other research questions, including:\n\n* The effect the study drug has on specific biomarkers, which are substances in the blood or in the fluid that surrounds the brain and spinal cord, known as Cerebrospinal Fluid (CSF)\n* How much study drug is in the blood and in the CSF, at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)\n* What effects the study drug has on ALS symptoms",[30,187],"Mutation in the Superoxide Dismutase-1 (SOD1) Gene",[189,190,191],"Symptomatic","Known pathogenic mutation","Predicted pathogenic mutation",{"date":193,"type":35},"2026-07-22",{"date":195,"type":35},"2024-08-28",{"date":197,"type":23},"2032-03-21",{"name":199,"class":42},"Regeneron Pharmaceuticals",{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":208,"targetDuration":4,"studyType":24,"phases":210,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":98},"100571414","phase-2-hd-tdcs-in-amyotrophic-lateral-sclerosis-a-multicenter-randomized-controlled-trial-100571414","NCT06719947","HD-tDCS in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial","High-Definition Transcranial Direct Current Stimulation (HD-tDCS) in Amyotrophic Lateral Sclerosis: A Multicenter Randomized Controlled Trial","tDCS-ALS","Inclusion Criteria:\n\n* Both sexes; diagnosis of ALS according to the revised El Escorial criteria;\n* Age between 18 and 80 years;\n* Forced Vital Capacity greater than 50% of predicted;\n* Sniff nasal inspiratory pressure greater than 40 cmH2O;\n* A telephone number to contact the care team and who signed the study consent form.\n\nExclusion Criteria:\n\n* Subjects who are unable to understand or perform any of the study procedures;\n* Subjects who do not agree to participate or voluntarily request withdrawal from the study at any time;\n* Subjects with cardiac, respiratory, or musculoskeletal comorbidities;\n* Subjects using invasive mechanical ventilation;\n* Subjects with a tracheostomy;\n* Subjects with a pacemaker;\n* Subjects with metallic brain implants or other electronic implants;\n* Subjects with a cochlear implant;\n* Subjects with epileptic activity or a history of epilepsy, or a family history of epilepsy;\n* Subjects with a history of stroke or tumor;\n* Subjects prone to severe hemodynamic fluctuations, acute infectious processes, and\u002For inflammatory conditions;\n* Pregnant women at the time of recruitment;\n* Subjects who are unable to complete the intervention protocol.",{"count":209,"type":23},80,[26,27],"Amyotrophic Lateral Sclerosis (ALS) is a nervous system disease that causes muscle weakness and rapidly progresses to the loss of mobility and functionality. Studies suggest that High-Definition Transcranial Direct Current Stimulation (HD-tDCS) is a technique for modulating motor cortical hyperexcitability. However, evidence on the use of HD-tDCS as a neuromodulator of the diaphragmatic motor cortex in people with ALS is inconclusive.",[30],[30,214,215,216],"Central Nervous System Diseases","Electric Stimulation Therapy","Transcranial Direct Current Stimulation","2026-07-17",{"date":219,"type":35},"2026-07-20",{"date":221,"type":35},"2025-11-28",{"date":223,"type":23},"2028-09-01",{"name":225,"class":74},"Universidade Federal do Rio Grande do Norte",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100647262","serum-neurofilaments-in-the-diagnosis-of-amyotrophic-lateral-sclerosis-100647262","NCT07706270","Serum Neurofilaments in the Diagnosis of Amyotrophic Lateral Sclerosis","Diagnostic Performance of Serum Neurofilaments in the Differential Diagnosis of Amyotrophic Lateral Sclerosis","DIAGONALS","Inclusion Criteria:\n\n* Be at least 18 years of age\n* Be able to undergo blood sampling (however, blood sampling is part of the standard examination and will not be performed exclusively for this study).\n* Patients with suspected ALS\n\nExclusion Criteria:\n\n-• Patients with recent stroke\n\n* Pregnant or breast-feeding women\n* Patient deprived of liberty by judicial or administrative decision, or hospitalization under duress\n* Adult protected by law (guardianship, curatorship)\n* Patient unable to understand and read information and consent forms in French\n* Person participating in another research study with an exclusion period still in progress.\n* Failure to obtain written informed consent after a period of reflection\n* Not affiliated to a social security scheme or beneficiary of such a scheme\n* Person unable to give consent",{"count":235,"type":23},138,"OBSERVATIONAL","Amyotrophic lateral sclerosis (ALS) is a serious neurodegenerative disease, often difficult to diagnose due to symptoms similar to other neurological pathologies. Diagnosis can take up to 14 months, although the rapid progression of the disease requires early detection. At present, there is no validated biomarker to aid diagnosis. Serum neurofilaments light chain (NfL), markers of neuronal degeneration, show great potential to help diagnose ALS early and assess disease severity. Recent research has shown that measurement of NfL in the blood can differentiate ALS from other neurological disorders, and new technologies are increasingly making it possible to perform these tests clinically.\n\nThe study hypothesis is that NfL blood levels, measured using clinical analyzers, could improve early ALS diagnosis, optimize patient recruitment for therapeutic trials and accelerate the assessment of treatment efficacy.\n\nThe primary objective is to evaluate the sensitivity and specificity of serum NfL for the diagnosis and differential diagnosis of amyotrophic lateral sclerosis (ALS) in newly recruited patients referred to the ALS Reference Center at Montpellier University Hospital. The diagnosis is established according to the revised El Escorial diagnostic criteria (see Appendix). This diagnosis is determined independently of the serum NfL concentration.",[30,239,240],"Neurodegenerative Disorders","Motor Neuron Diseases",[138,242,243,244],"neurofilament proteins","glial fibrillary acid protein","early diagnosis","2026-07-16",{"date":219,"type":35},{"date":248,"type":23},"2026-08-01",{"date":250,"type":23},"2028-08-01",{"name":252,"class":74},"University Hospital, Montpellier",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":260,"targetDuration":4,"studyType":24,"phases":262,"briefSummary":263,"conditions":264,"keywords":273,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":75},"100633072","interfacing-with-neurotechnology-to-expand-neural-throughput-intent-100633072","NCT07521930","Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)","INTENT","Inclusion Criteria:\n\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in Locked In Syndrome (LIS) and amyotrophic lateral sclerosis (ALS), including the bulbar variant of ALS.\n* Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\\*, traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). \\*Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage.\n* Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.\n* Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (\\\u003C 3) throughout the lower limbs.\n* Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\\\u003C3) throughout the upper limbs.\n* Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through speech or eye movement\n* Stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel to study location up to five days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Corrected visual acuity sufficient for use of computer monitor\n\nExclusion Criteria:\n\n* Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).\n* Contraindications to MRI or anticipated need for an MRI during the study period\n* Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)\n* Chronic anti-coagulation and medical contraindication to temporary suspension for surgery\n* Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)\n* Participants with dental caries and a significant risk of dental or periodontal infection\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or ongoing chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Persistent suicidal ideation within the past 12 months.\n* History of substance use disorder within the past year\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control",{"count":261,"type":23},5,[54],"The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.",[265,30,266,267,268,269,270,271,272],"Tetraplegia\u002FTetraparesis","Muscular Disorders, Atrophic","Brain Stem Stroke","Spinal Cord Injuries (SCI)","Muscular Dystrophies","Muscular Atrophy, Progressive","Pontine Hemorrhage","Pontine Infarction",[274,275],"Assistive device","Brain Computer Interface","2026-07-07",{"date":278,"type":35},"2026-07-08",{"date":280,"type":23},"2026-08",{"date":282,"type":23},"2028-12",{"name":284,"class":74},"Johns Hopkins University",{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":24,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":75},"100594323","phase-1-intestinal-microbiome-transplant-in-als-100594323","NCT07017946","Intestinal Microbiome Transplant in ALS","A Pilot Trial to Investigate the Safety and Efficacy of Intestinal Microbiome Transplant (MTT) in People With Amyotrophic Lateral Sclerosis","Inclusion Criteria:\n\n* Diagnosis of ALS according to Gold Coast Criteria\n* Age: 18+ years at enrollment\n* Fast-progressing (ALSFRS-R change of at least 1.5 points per month between last 2 measurements at screening)\n* Modestly but not severely affected (ALSFRS-R score at or above 24 at screening)\n* Able to swallow capsules and expected to be able to for the duration of the trial (ALSFRS-R \"swallowing\" score of 3 or 4 at screening)\n* Expected to survive for the duration of the trial\n* Taking any combination of riluzole, edaravone, and\u002For tofersen at a stable dose for 30 days prior to screening, or not taking any of these and not expected to during the study.\n* Capable of giving written consent.\n* If sexually active, must agree to use contraceptive or abstinence for duration of treatment.\n* Females of child-bearing age must have negative pregnancy test at screening.\n\nExclusion Criteria:\n\n* Concurrent illness or laboratory abnormalities that could confound the measurement of ALS progression or the microbiome or interfere with the ability to complete the study.\n* Taking probiotics, nutraceuticals, or herbal remedies within 2 weeks of screening\n* Taking antibiotics within 3 months of screening.\n* Taking any investigational study drug within 30 days of screening or five half-lives of the prior agent.\n* Previous exposure to MTT.\n* Pregnancy.\n* Known specific food allergy with anaphylaxis\n* Other co-morbid conditions that, in the opinion of the study investigator, place the participant at increased risk of complications, interfere with study participation or compliance, or confound study objectives.",{"count":131,"type":23},[86,26],"This is a 24-week study of intestinal microbiome transplant in people with ALS. All participants will be evaluated clinically in person for 4 visits. Blood and mailed\u002F fresh stool samples will also be collected. Blood samples will be used to determine changes in neurofilament light chain over time. Stool samples will be processed for microbiome analysis. Participants will have phone visits to further evaluate safety and tolerability. They will then undergo antibiotic conditioning and a standard bowel preparation before being assigned to the investigational product, MTP-101C .",[296],"Amyotrophic Lateral Sclerosis ALS",{"date":278,"type":35},{"date":299,"type":35},"2026-01-27",{"date":301,"type":23},"2026-11-01",{"name":303,"class":74},"Duke University",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":311,"sex":18,"minAge":19,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":24,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":75},"100609350","identification-of-early-markers-for-als-100609350","NCT07213440","Identification of Early Markers for ALS","PremodiALS","Inclusion Criteria:\n\nFIRST GROUP: Premotor gene mutation carriers (PGMC):\n\n* 18-90 years of age\n* Provision of a written informed consent\n* Affiliation with a social security scheme or beneficiary of such a scheme\n* Diagnosed by a clinically certified laboratory with a disease- causing mutation in a known ALS gene by predictive genetic testing\n* No symptoms of motor neuron disease explainable otherwise than by mutation in a known ALS gene\n\nSECOND GROUP: Control subjects to premotor gene mutation carriers (CTR):\n\n* 18-90 years of age\n* Provision of a written informed consent\n* Affiliation with a social security scheme or beneficiary of such a scheme\n* No known genetic mutation and no known ALS disease in close family\n* No diagnosed motor-neuron disease\n\nTHIRD GROUP: ALS (EALS) \u002F ALS mimics (MIM)\n\n* 18-90 years of age\n* provision of a written informed consent\n* affiliation with a social security scheme or beneficiary of such a scheme\n* Patients with pure motor symptom or early ALS (EALS) or ALS mimics (MIM)\n\nEALS are patients with pure motor symptom \u002F early motor symptoms of ALS, including those, where the diagnosis of ALS can already be made. These may be patients who meet the following criteria:\n\nAccording to El Escorial criteria : patients who can be classified as possible ALS or those who show upper motor neuron (UMN) signs only or lower motor neuron (LMN) signs only, so that classification as possible ALS is also not possible. Symptoms should not persist for more than 12 months.\n\nAccording to Gold Coast criteria: Patients who do not fulfill the criterion of temporal progression or patients who only show UMN signs or only LMN signs in one region and thus do not fulfill the diagnostic criteria of ALS.\n\nExclusion Criteria:\n\n* Inability to express consent to the study\n* Persons subject to a judicial safeguard measure, under guardianship or curatorship.\n* Linguistic incapacity or psychic refusal to read the information.\n* Pregnant women\n* Foreseen inability to attend scheduled visits\n* Persons refusing to take one of the following samples: Acquisition of blood samples, Acquisition of tear fluid samples, Acquisition of urine sample",true,"90 Years",{"count":314,"type":23},60,[54],"Although several molecules have been proposed as biomarker candidates, a clinically established signature for an early or even premotor diagnosis of ALS is not available. Due to the already advanced, disease stage at the time of diagnosis as well as rapid disease progression, an early diagnosis is mandatory for efficacious disease-modifying therapies.\n\nIn this project, the investigators will develop a clinical molecular fingerprint of PGMC that will provide insight into the molecular pathogenesis of ALS and allow earlier diagnosis.",[30],"2026-07-03",{"date":276,"type":35},{"date":321,"type":35},"2024-09-30",{"date":323,"type":23},"2027-04",{"name":325,"class":326},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":24,"phases":337,"briefSummary":338,"conditions":339,"keywords":349,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100598472","phase-2-a-clinical-trial-of-early-ventilation-in-amyotrophic-lateral-sclerosis-event-als-100598472","NCT07071935","A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","A Pilot Randomized Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS)","EVENT ALS","Inclusion Criteria:\n\n* Diagnosed with ALS using the Gold Coast Criteria within the last 6 months\n* Age ≥18 years\n* Willingness and ability to participate in study procedures\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n1. Current or prior or recommended\u002Fprescribed use of NIV including:\n\n   i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or \"CPAP\" therapy\n2. Forced vital capacity \\\u003C50% of predicted normal\n3. Maximal inspiratory pressure \\> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded)\n4. Chronic use of supplemental oxygen at any part of the day\n5. Enrollment in hospice\n6. Current tracheostomy\n7. Prior history of sleep apnea where non-invasive ventilation was used or recommended\n8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks\n9. Coughing up blood\n10. Myocardial infarction in the previous 4 weeks\n11. Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor)\n12. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician",{"count":336,"type":23},48,[26],"Amyotrophic lateral sclerosis (ALS) is a disease that causes weakness of the muscles of the body. The disease can eventually lead to severe breathing problems, which is the most common cause of death from ALS. The treatment for breathing is non-invasive ventilation (NIV). It is a machine that helps a person breathe by pushing air in and out of their lungs through a mask worn over the face. Research has shown that NIV can improve the quality of life and survival of someone with ALS. Unfortunately, NIV is not equally beneficial for everyone. The investigators do not yet know the best time or method for starting NIV in ALS. Europe and Canada allow starting NIV much earlier in ALS than the United States. Current recommendations for starting NIV are based on the opinion of experts rather than large research studies. Medical insurance companies will not cover NIV until significant breathing weakness occurs. After NIV is started, there is no evidence-based guidance on the best way to adjust NIV to benefit patients as much as possible. Some patients have difficulty tolerating NIV, but it is not clear how to identify these individuals ahead of time.\n\nThe investigators have created a new prediction tool that can identify patients at high risk of breathing problems within the next 6 months. This may help the study team identify who is more likely to benefit from starting NIV early. The investigators have published a paper that shows that NIV helps people with ALS live longer. This paper also showed that patients get more benefit with use NIV for at least 4 hours per day. The investigators published another paper that measured a gas called carbon dioxide (CO2), which goes high if someone's breathing is weakened. This paper showed that patients with ALS may live longer when CO2 levels are lowered using NIV. The investigators also have data suggesting that certain characteristics may predict who is less likely to use NIV at least 4 hours per day.\n\nIn this study, the investigators will collect pilot data on starting early NIV in individuals with ALS who do not yet meet insurance criteria for covering NIV. The research team will first use their previously published prediction tool to identify patient risk. Then, subjects would be randomized to start early NIV or to usual care. The usual care group would eventually start NIV as would occur if the participants were not in the study.\n\nThe purpose of this study is to collect data to help the investigators plan a larger randomized clinical trial. This study has 4 objectives. First, the project aims to identify individuals who would benefit from earlier NIV. The research team will use the original prediction tool to identify risk of severe breathing problems within the next 6 months. Second, the project aims to show that it is feasible to start NIV early. Third, the project aims to gather data on the effect of randomization on symptoms, CO2 levels, and outcomes. Fourth, the project aims to identify traits that may make someone less likely to use NIV.",[30,340,341,342,343,344,345,346,347,348],"Chronic Respiratory Failure","Neuromuscular Disease Patients","Neuromuscular Disease","Respiratory Insufficiency","Respiratory Insufficiency Requiring Mechanical Ventilation","Positive Pressure Ventilation","Non-invasive Ventilation","Non-invasive Ventilation Support","Non-invasive Ventilatory Support",[350,351,352,138],"chronic respiratory failure","chronic neuromuscular respiratory failure","non-invasive ventilation","2026-06-25",{"date":355,"type":35},"2026-06-26",{"date":357,"type":35},"2026-06-11",{"date":359,"type":23},"2029-05",{"name":361,"class":74},"University of Pennsylvania",3,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":370,"enrollmentInfo":371,"targetDuration":373,"studyType":236,"phases":4,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":75},"100610866","healing-als-registry-observational-study-haros-100610866","NCT07233148","Healing ALS Registry Observational Study (HAROS)","HAROS","Inclusion Criteria:\n\n* Diagnosed with ALS, MND or PLS\n\nExclusion Criteria:\n\n* Smokers","110 Years",{"count":372,"type":23},1000,"10 Years","This is a prospective, observational, online study of people diagnosed with ALS, MND or PLS referred to as HAROS (Healing ALS Registry Observational Study). Participants will enter information into an online ALS registry once per month, including their ALSFRS-R data, certain other symptoms, dietary intake, supplements, medications and other therapies, both conventional and integrative. Participants will also enter the hours spent on optional self-study and free online education. The investigators will assess the effectiveness of various therapies and education by measuring physical outcomes.",[30,376,377],"Motor Neuron Disease (MND)","Primary Lateral Sclerosis (PLS)",[62,379,380,163,381,382,383],"PLS","MND","Primary Lateral Sclerosis","Motor Neuron Disease","Motor Neurone Disease","2026-06-19",{"date":386,"type":35},"2026-06-24",{"date":388,"type":35},"2026-01-26",{"date":390,"type":23},"2036-03-31",{"name":392,"class":74},"Healing Advocates Registry and Ministry",{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":400,"targetDuration":4,"studyType":24,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":84},"100621319","phase-1-a-clinical-trial-to-evaluate-nb-4746-in-participants-with-amyotrophic-lateral-sclerosis-100621319","NCT07369076","A Clinical Trial to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.","A Phase 1b\u002F2 Study to Evaluate NB-4746 in Participants With Amyotrophic Lateral Sclerosis.","Inclusion Criteria:\n\n\\- ALS Criteria for Phase 1b:\n\n1. Participants in Phase 1b must have:\n\n   1. Diagnosis of ALS per Gold Coast Criteria; and\n   2. Symptom onset ≤48 months prior to randomization on Day 1. Date of first ALS symptom (any ALS symptom) onset is defined as the onset of weakness in the limbs, bulbar region, or trunk. Weakness in the bulbar region includes dysarthria and dysphagia.\n\n      * ALS Criteria for Phase 2:\n2. Participants in Phase 2 must have:\n\n   1. Diagnosis of ALS per Gold Coast Criteria; and\n   2. Symptom onset ≤24 months prior to randomization on Day 1. Date of first ALS symptom (any ALS symptom) onset is defined as the onset of weakness in the limbs, bulbar region, or trunk. Weakness in the bulbar region includes dysarthria and dysphagia.\n\n      * Additional Inclusion Criteria (All Participants):\n3. Male or female participants aged ≥18 years and ≤80 years at the time of signing informed consent.\n4. Participants must demonstrate functional oral intake and be independent of enteral nutritional support (e.g., PEG, G-tube) at the time of screening per Principal Investigator's judgement.\n5. Slow vital capacity (SVC) ≥60% of predicted at Screening.\n6. If taking riluzole, participant must be on a stable dose for ≥60 days prior to Screening lab blood draw.\n7. If taking edaravone, participant must have completed at least 1 cycle of edaravone prior to screening labs.\n8. Willing to adhere to contraceptive requirements during the study period as described in Appendix 1.\n9. Capable of giving signed informed consent, as described in Section 13.2.2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\n1. Presence of tracheostomy or permanent assisted ventilation; defined as \\> 22 hours daily of mechanical ventilation for more than 1 week (7 days).\n2. History or presence of clinically significant uncontrolled medical conditions (other than ALS) that include cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs; or interfering with the interpretation of data as determined by the Investigator.\n3. Lifetime history of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Fully resected basal cell carcinoma and squamous cell carcinoma with no evidence of recurrence for 1 year are permitted.\n4. Female participants who have a positive serum pregnancy test at Screening, positive urine pregnancy test on Day 1, or who are breastfeeding on Day 1.\n5. Has a spinal deformity or other condition that may prevent the performance of a lumbar puncture.\n6. International Normalized Ratio (INR) \\>1.4, platelet count \\\u003C50,000\u002FμL, or use of warfarin, heparin, or direct oral anticoagulants.\n7. History of Class III\u002FIV heart failure (per New York Heart Association \\[NYHA\\]).\n8. Inability to swallow or tolerate oral medications at Screening.\n9. Current participation in any other investigational drug study or receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) before Screening.\n10. Known sensitivity to the NB-4746 study drug or any of the formulation components.\n11. Has received NB-4746 at any time prior to initial Screening.\n12. Any other reason that, in the opinion of the Investigator, would confound the conduct of this study or the interpretation of the results or that could compromise the participant's safety.\n13. Currently taking or planning to receive tofersen for the treatment of ALS.\n14. If a participant does not transition to the OLE in ≤30 days following completion of the main study, the participant will need to be rescreened for laboratory criteria and contraception\u002Fpregnancy criteria.",{"count":209,"type":23},[86,26],"The purpose of this trial is to learn about the effects of NB-4746 compared with placebo in people with amyotrophic lateral sclerosis.\n\nThe questions this trial aims to answer in comparing NB-4746 to placebo are:\n\n* What adverse events associated with taking NB-4746 are reported during this trial? (An adverse event is any sign or symptom that participants have during a trial. Adverse events may or may not be caused by treatments in the trial.)\n* How does NB-4746 move into, through, and out of the body of the participants?\n* What is the change in the level of neurofilament light (NfL) in the participants' blood? (NfL is a marker used to measure the extent of damage to the nerve cells.)\n\nThis trial has 2 parts. The trial doctors will start Part A before starting Part B of the trial. Participants have an option to enter the open label extension after completing Part A or Part B.\n\nPart A: Participants will be randomly placed into 1 of the 3 groups. There are equal chances to be assigned to either group. Group 1: Participants will receive NB-4746 capsules at a low dose to take by mouth twice daily for 1 month. Group 2: Participants will receive NB-4746 capsules at a high dose to take by mouth twice daily for 1 month. Group 3: Participants will receive placebo capsules to take twice daily for approximately 1 month.\n\nPart B: Participants will be randomly placed into 1 of the 2 groups. There are equal chances to be assigned to either group. Group 1: Participants will receive NB-4746 capsules at a dose determined by Part A to take by mouth twice daily for 12 weeks. Group 2: Participants will receive placebo capsules to take twice daily for approximately 12 weeks.\n\nNone of the participants, trial doctors, or trial staff will know which treatment the participants will receive during Part A or B. Some trials are done this way because knowing what treatment the participants receive can affect the results of the trial. Doing a trial this way helps to make sure that the results are looked at with fairness across all treatments.\n\nOpen-Label Extension: Upon the completion of Part A or Part B, the doctor will verify the participant's willingness to continue receiving study treatment. This open label extension continues until each participant completes up to 1 year of treatment. The trial doctors will check participants' ALS and general health throughout the trial.",[30],[163,62],"2026-06-17",{"date":407,"type":35},"2026-06-22",{"date":409,"type":35},"2026-03-04",{"date":411,"type":23},"2028-02",{"name":413,"class":42},"Nura Bio",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":380,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":24,"phases":423,"briefSummary":424,"conditions":425,"keywords":427,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":75},"100607348","investigating-the-impact-of-electrical-stimulation-on-facial-pain-jaw-movement-and-oral-health-in-people-with-motor-neuron-disease-100607348","NCT07187388","Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.","The Impact of Transcutaneous Electrical Stimulation on Facial Pain, Jaw Mobility, and Oral Health in Individuals With Motor Neuron Disease.","Inclusion Criteria:\n\n* Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited) OR diagnosis of definite PLS by the treating neurologist and based on the consensus diagnostic criteria for PLS\n* Subjective report of jaw pain, indicated by a NRS score of \\> or = 3\u002F10.\n\nExclusion Criteria:\n\n* history of head or neck cancer\n* history of CVA\n* history of past facial surgery with hardware placement\n* history of pacemaker\n* diagnosis of significant cognitive impairment by the treating physician\n* history of seizures or diagnosis of epilepsy\n* open wound at the area of electrode placement\n* complete loss of sensation at the area of electrode placement",{"count":422,"type":23},10,[54],"The goal of this clinical trial is to evaluate the impact of non-invasive electrical stimulation, when placed on the facial muscles can reduce facial pain and improve jaw mobility, and chewing in individuals with Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS). The secondary goal is to evaluate the impact of non-invasive electrical stimulation on patient reported difficulty performing oral hygiene tasks in individuals with ALS and PLS. Participants will attend one in-person clinic visit and participate in one telephone interview 24 hours after the treatment. The clinic visit will include pre-intervention assessments, a single 30-minute treatment of electrical stimulation followed by post-intervention assessments.\n\nThe assessments will include a self-rating of jaw and facial pain, a range of motion test where participants will be asked to open their jaw as wide and as far to the side as possible, and a chewing efficiency test using a saltine cracker. Twenty-four hours later, participants will receive a follow-up phone call to self-rate their facial pain and report any difficulty performing oral hygiene tasks.\n\nThe treatment consists of a single 30-minute electrical stimulation session. Electrode pads will be placed on the participant's facial region, specifically over the masseter muscle belly and the TMJ area, while the participant is seated comfortably. The pads will be connected to an FDA-approved electrical stimulator, and the current will be adjusted to the participant's comfort level. Once set, the participant will remain seated for 30 minutes. At the end of the session, the stimulator will be turned off and the electrode pads removed.",[30,377,426],"Motor Neuron Disease, Amyotrophic Lateral Sclerosis",[163,381,62,379,382,380,428,429],"Facial Pain","jaw pain","2026-05-22",{"date":432,"type":35},"2026-05-27",{"date":434,"type":35},"2026-04-02",{"date":436,"type":23},"2026-08-13",{"name":438,"class":74},"Nova Southeastern University",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":312,"enrollmentInfo":445,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100638430","transcutaneous-superior-laryngeal-nerve-stimulation-to-upregulate-swallowing-frequency-and-urge-to-swallow-in-patients-living-with-als-100638430","NCT07606235","Transcutaneous Superior Laryngeal Nerve Stimulation to Upregulate Swallowing Frequency and Urge to Swallow in Patients Living With ALS","Inclusion Criteria:\n\n* Confirmed diagnosis of ALS (El-Escorial Criteria)\n* ALS FRS Bulbar Subscore of ≤ 10 and ≥ 3.\n* Functional Oral Intake scale score ≥ 2\n\nExclusion Criteria:\n\n* A diagnosis of significant cognitive impairment or frontotemporal dementia per the treating neurologist or neuropsychologist,\n* Current nasogastric tube placement\n* Current head and neck carcinoma\n* Pacemaker or implanted defibrillator or history of diagnosed arrhythmia, bradycardia, or repeated attacks of hypotension,\n* Implanted vagal nerve stimulator\n* Current pregnancy\n* History of epilepsy\n* Infected, broken or inflamed skin on the neck, or impaired sensation at the site of sEMG or TENS placement\n* Living greater than 50 miles from the NSU clinic round trip\n* Any clinical reason that this stimulation may not be a suitable treatment according to the principal investigator.",{"count":261,"type":23},[54],"Prospective, single-arm pilot study evaluating transcutaneous electrical nerve stimulation of the superior laryngeal nerve (TENS-SLN) in individuals with ALS.\n\nUp to 5 participants with confirmed ALS and bulbar involvement will be enrolled.\n\nPrimary outcomes: swallowing frequency and perceived urge to swallow. Participants complete a baseline visit, followed by two supervised treatment sessions within one week, and a final post-treatment evaluation.\n\nOptional visits (up to 2) may be used to individualize stimulation parameters prior to treatment.\n\nSwallowing function will be assessed using physiological monitoring, fiberoptic endoscopy, and videofluoroscopic swallow study (VFSS).\n\nTENS-SLN is a non-invasive neuromodulation approach targeting sensory pathways to facilitate swallowing without inducing muscle contraction.\n\nThis pilot study is designed to assess feasibility, safety, and preliminary effect sizes to inform future randomized trials, and is not powered to determine efficacy.",[30,449,450],"Dysphagia","Dystussia","2026-05-18",{"date":453,"type":35},"2026-05-26",{"date":455,"type":23},"2026-06",{"date":457,"type":23},"2026-12",{"name":438,"class":74},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":75},"100562810","influence-of-olfacto-gustatory-sensoriality-on-the-nutritional-status-of-patients-with-amyotrophic-lateral-sclerosis-100562810","NCT06608004","Influence of Olfacto-gustatory Sensoriality on the Nutritional Status of Patients With Amyotrophic Lateral Sclerosis","GOUSLA","Inclusion Criteria:\n\nInclusion criteria\\*:\n\n* Incident cases of definite or probable ALS according to El-Escorial criteria (3) followed up at the participating regional centre of competence\n* Patient aged over 18\n* Patient fluent in French\n* Patient having given oral consent\n\nExclusion Criteria:\n\n* Patients with an acute infection undergoing antibiotic treatment at the time of inclusion\n* Patients with psychiatric, cognitive or neurological disorders making it impossible to assess food preferences\n* Patient with a known food allergy\n* Patients with excessive alcohol consumption (≥ 10 standard drinks per week)\n* Patients who have stopped smoking for less than 1 month\n* Patients with severe bulbar involvement from the outset, preventing swallowing, patients with aphagia or patients eating exclusively via a gastrostomy\n* Patient with severe diaphragmatic impairment requiring NIV from the outset\n* Person not affiliated to or not benefiting from a social security scheme\n* Person under legal protection (curatorship, guardianship)\n* Persons subject to a legal protection measure\n* Pregnant women, women in labour or breastfeeding mothers\n* An adult who is incapable or unable to give consent\n* Minors",{"count":314,"type":23},"Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterised by progressive diffuse muscular paralysis due to the inexorable loss of motor neurons in the primary motor cortex, the corticospinal tract, the brain stem and the spinal cord.\n\nOver the course of the disease, when the phrenic motor neurons are involved, diaphragmatic weakness develops, leading to restrictive respiratory failure, which is the main cause of morbidity and mortality. Non-invasive ventilation (NIV) compensates for diaphragm failure and corrects the associated symptoms, and has been shown to prolong patient survival and improve quality of life.\n\nUndernutrition is another recognised prognostic factor. Several mechanisms have been described, foremost of which are a state of hypermetabolism and a reduction in food intake secondary to chewing difficulties, dysphagia, a loss of dexterity in the upper limbs, a disturbance in salivary secretion or psychological disorders. In addition, diaphragmatic dysfunction plays a direct role in the onset of undernutrition, as compensatory contraction of the accessory neck muscles increases resting energy expenditure.\n\nHowever, the hedonic sensations triggered by a meal play a role in controlling food intake beyond the simple energy balance between calorie intake and energy expenditure. Olfacto-gustatory sensoriality could therefore play a role in the nutritional status of patients suffering from ALS.\n\nDiaphragmatic dysfunction may also influence nutritional status by other mechanisms. For example, the reduction in inspiratory capacity associated with diaphragmatic insufficiency reduces olfaction in a group of tetraplegic patients. Central sensory impairment could exacerbate this phenomenon. Although it is conventionally considered that there are no sensory manifestations during the course of ALS, minor but diffuse abnormalities of the nerves and sensory action potentials have been observed. A central alteration in olfacto-gustatory sensoriality could be part of the neurological manifestations of ALS. In addition, olfactory deficits occur in other neuromuscular diseases with central involvement, such as myasthenia, Parkinson\\'s or Alzheimer\\'s disease, in the absence of concomitant cognitive or diaphragmatic impairment.\n\nOur hypothesis is that impaired olfacto-gustatory function favours the onset of undernutrition in ALS.\n\nCurrent nutritional management consists of ensuring adequate calorie intake by prescribing oral food supplements or inserting a gastrostomy. Taking personalised account of food preferences during dietary advice or of a potential olfacto-gustatory deficit, by reinforcing smells or tastes during food consumption, would be an interesting additional therapeutic avenue for improving patients\\' nutritional status, quality of life and prognosis",[30],"2026-05-13",{"date":471,"type":35},"2026-05-15",{"date":473,"type":35},"2026-05-12",{"date":475,"type":23},"2029-05-12",{"name":477,"class":74},"Centre Hospitalier Universitaire Dijon",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":24,"phases":486,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":494,"locationsCount":495},"100639582","phase-1-a-widely-inclusive-hybrid-decentralized-pilot-trial-utilizing--hydroxy--methylbutyrate-to-lower-igfbp7-levels-in-people-with-als-100639582","NCT07589764","A Widely Inclusive, Hybrid-Decentralized Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS","Inclusion Criteria:\n\n1. Male or female aged at least 18 years.\n2. Sporadic or familial ALS diagnosed as per Gold Coast Criteria (37).\n3. Patient is able to understand and express informed consent (in the opinion of the site investigator).\n4. Patient is able to read and write English.\n5. Patient is expected to survive for the duration of the trial.\n6. Women must not be pregnant (will have evidence of a negative pregnancy test obtained by study team at baseline, or by local physician within past 7 days or be post-menopausal)\n7. Women must not be able to become pregnant (e.g., post-menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception, or other hormonal contraception, for example patch or contraceptive ring), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.\n\nExclusion Criteria:\n\n1. Actively or recently (within past 30 days) participating in another intervention trial.\n2. Currently or recently (within 30 days) taking HMB\n3. Prior side effects from HMB deemed to be significant by the investigator\n4. Patient has a medical or psychiatric illness that could in the investigator's opinion interfere with the patient's ability to participate in this study.\n5. Pregnant women or women currently breastfeeding.\n6. Elevated serum calcium or vitamin D levels.\n7. Life expectancy shorter than the duration of the trial.",{"count":485,"type":23},100,[86],"This is an open label trial of a supplement called HMB in patients with ALS. The researchers are evaluating its safety and tolerability, as well as its ability to lower insulin-like growth-factor binding protein 7 (IGFBP7) and Neurofilament light chain levels (NFL) and to slow ALS Functional Rating Scale, Revised (ALSFRS-R) progression.",[296],"2026-05-11",{"date":471,"type":35},{"date":492,"type":23},"2026-07-01",{"date":248,"type":23},{"name":303,"class":74},2,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":24,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":75},"100583501","hypercaloric-peg-nutrition-in-als-to-sustain-energy-homeostasis-100583501","NCT06877143","Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis","PEGASUS","Inclusion Criteria:\n\n* Possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria 1\n* Loss of ALS functional rating scale revised (ALSFRS-R) of ≥ 0.33 points per month since onset (first paresis) based on the formula: (48 - Score at Screening Visit) \u002F (Months between Onset and Screening Visit)\n* Nutrition via PEG\n* Age ≥18 years\n* Intake of a stable dose of riluzole for at least 4 weeks, or no riluzole\n* Capable of thoroughly understanding all information given and giving full informed consent according to GCP\n\nExclusion Criteria:\n\n* Previous participation in another interventional study within the preceding 4 weeks\n* Absence of adequate social support and cooperation, or personal motivation (in the judgment of the investigator) to complete the study satisfactorily\n* Pregnancy or breast-feeding females\n* Evidence of a major psychiatric disorder or clinically evident dementia",{"count":504,"type":23},76,[54],"Weight loss is a known negative prognostic factor in amyotrophic lateral sclerosis (ALS). Over the last years, various interventional studies targeting the energy deficit in ALS yielded promising results; however,it is still unclear which kind of nutrition or nutritional supplement is most beneficial. Moreover, there is lack of evidence regarding interventions in patients with a PEG in later disease stages.In a pilot study conducted in 2013, it was demonstrated that body weight can be stabilized in ALS by applying either a fat-rich or carbohydrate-rich high-caloric food supplement. In 2014, Wills et al. conducted a placebo-controlled randomized controlled pilot study, which indicated that a carbohydrate-rich, hypercaloric diet, consisting in 125% of estimated energy requirements as determined by indirect calorimetry, in patients fed via percutaneous endoscopic gastrostomy was safe and well tolerated. Moreover, these patients showed longer survival than patients fed with a fat-rich, hypercaloric diet or an isocaloric diet . Hypercaloric, high-carbohydrate diet also showed beneficial effects on body weight and Body Mass Index . Although these results were promising, the low number of patients (n=24) was a severe limiting factor of this study. The aim of this study is to investigate the effect of a hypercaloric PEG nutrition, consisting of 120% of estimated calorie requierements, compared to an isocaloric nutrition. Individual energy requirement is determined by performing indirect calorimetry and activity questionnaire. The investigators hypothsize, that a hypercaloric PEG nutrition slows down disease progression as measured by neurofilament light chains (NfL) in serum after 6 months compared to placebo. Power calculation relies on the results of the lipids and calories for ALS (LIPCAL-ALS) study which tested the effect of an oral high-caloric fatty nutritional supplement in ALS. The study revealed that NfL serum values declined significantly in the intervention group while remaining stable in the placebo group over the course of the study. Assuming a similar effect size, we calculated that 76 patients had to be included in the current trial.",[30],[62,509,510,511],"PEG","hypercaloric nutrition","energy deficit","2026-04-30",{"date":514,"type":35},"2026-05-06",{"date":516,"type":35},"2025-03-01",{"date":518,"type":23},"2031-09-01",{"name":520,"class":74},"University of Ulm",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":311,"sex":18,"minAge":19,"maxAge":312,"enrollmentInfo":528,"targetDuration":4,"studyType":24,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":75},"100579040","examining-interactions-between-pals-and-caregivers-100579040","NCT06819124","Examining Interactions Between PALS and Caregivers","Examining Interactions Between Persons With ALS and Caregivers","Inclusion Criteria:\n\nSpeakers with amyotrophic lateral sclerosis (ALS) (PALS-people with ALS)\n\n* diagnosis of ALS following the revised EL Escorial criteria\n* no history of other neurological conditions (e.g., stroke)\n* no cognitive impairment assessed by Telephone Montreal Cognitive Assessment (mini MoCA)\n* detectable speech disturbance according to the ALS Functional Rating Scale-Revised (ALSFRS-R)\n* the ability to produce single words\n* being a native speaker of American English (AE).\n\nCaregivers\n\n* being a caregiver of a participant with ALS\n* being a native speaker of American English (AE).\n\nExclusion Criteria:\n\n\\- None - if volunteer meets the inclusion criteria, then they will be enrolled",{"count":529,"type":23},152,[54],"The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers.\n\nThe question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time?\n\nParticipants will read words and sentences while they are interacting with their caregivers.",[30],"2026-04-01",{"date":535,"type":35},"2026-04-06",{"date":537,"type":35},"2025-01-22",{"date":539,"type":23},"2029-02-28",{"name":541,"class":74},"Penn State University",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":24,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":570},"100627907","do-video-recordings-of-multidisciplinary-clinics-improve-quality-of-life-for-people-with-als-and-their-caregivers-100627907","NCT07454733","Do Video Recordings of Multidisciplinary Clinics Improve Quality of Life for People With ALS and Their Caregivers?","Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis Visit Communication on Patient and Caregiver Quality of Life","VITALS","Inclusion Criteria for People with ALS:\n\n* Diagnosis of ALS by either El- Escorial or Gold Coast Criteria\n* ≥18 years of age\n* Plan to attend MDC visits for 12 months\n* Speak English or Spanish\n* Presence of a caregiver (defined as someone who assists with care) who is also participating in the VITALS trial\n* Projected life expectancy of at least 12 months as determined by the site investigator.\n\nExclusion Criteria for People with ALS:\n\n* Unable or unwilling to provide informed consent or follow study procedures\n* Significant cognitive impairment, clinical dementia, or unstable psychiatric illness (including, but not limited to, psychosis, active suicidal ideation, suicide attempt, or untreated major depression) as determined by the site investigator\n* Current pregnancy based on participant self-report;\n* Unable to access the internet;\n* Do not have access to a personal or shared email and are not interested in creating a personal or shared email;\n* Do not wish to create a patient portal account, if they do not already have one;\n* Uncorrected hearing or visual impairment that would impair the ability to view video recordings;\n* Incarcerated.\n\nInclusion Criteria for Caregivers:\n\n* Agree to their identified role as a caregiver of a patient with ALS participating in the VITALS trial;\n* Speak English or Spanish;\n* ≥18 years of age.\n\nExclusion Criteria for Caregivers:\n\n* Unable or unwilling to provide consent or follow study procedures;\n* Unable to access the internet;\n* Do not have access to a personal or shared email and are not interested in creating a personal or shared email;\n* Uncorrected hearing or visual impairment;\n* Professional caregiver for the patient;\n* Incarcerated.",{"count":551,"type":23},800,[54],"Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States. The gold standard of care for people with ALS is multidisciplinary clinics (MDC). In these multidisciplinary clinics, which occur every 3 to 4 months, people with ALS see up to 12 different healthcare providers (e.g., speech therapy, physical therapy, the ALS doctor). These clinics can last from three to five hours, and across these three to five hours people with ALS and their caregivers receive a lot of information that is critical to the care and quality of life for people with ALS. However, this information can be difficult to remember given the large amount of information that is conveyed. The current standard for providing take-home information about the visit is to provide patients with a written after-visit summary and access to their doctor's notes about the visit, typically through the patient portal. This study tests whether providing participants with video recordings of their MDC visits improves their quality of life and the quality of life of their caregivers. The study will enroll 400 pairs of people with ALS and their caregivers from eight different sites in the United States. Half of the participants in the study will receive their after-visit summary notes (the NOTES condition) and the other half of the participants will receive both their summary notes, but will also receive video recordings of their MDC visits that they can watch on their own at home (the VIDEO condition). The study will last for 12 months, with participants receiving NOTES or VIDEO at each of their regularly-scheduled MDCs during the 12 months. The study will test whether caregiver and patient participants in the VIDEO condition experience better quality of life than those in the NOTES condition at 1 month, 6 months, and 12 months from study enrollment. The results of this study will help determine what is the most effective approach to communicating MDC information to people with ALS and their caregivers.",[30],[556,557,558,559,560],"amyotrophic lateral sclerosis (ALS)","Open Notes","Open Recordings","video recording","after-visit summaries","2026-03-03",{"date":563,"type":35},"2026-03-06",{"date":565,"type":23},"2026-06-01",{"date":567,"type":23},"2029-10-01",{"name":569,"class":74},"Trustees of Dartmouth College",7,{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":4,"eligibilityCriteria":577,"healthyVolunteers":311,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":580,"conditions":581,"keywords":596,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":75},"100303705","retinal-imaging-in-neurodegenerative-disease-100303705","NCT03233646","Retinal Imaging in Neurodegenerative Disease","Evaluating the Retinal and Choroidal Microvasculature and Structure Using Multimodal Retinal and Choroidal Imaging in Neurodegenerative Disease: iMIND Research Study","Inclusion Criteria:\n\n* Adults with neurodegenerative disease ((MCI, PD, AD, FTD, DLB, ALS, MS, HD, TBI, concussion, PTSD and other neurodegenerations as well as Down Syndrome)\n* Adults without neurodegenerative disease\n\nExclusion Criteria:\n\n* Inability to cooperate with or complete testing or other neurologic or age- related ocular conditions that would impact image acquisition.\n* Eyes that have had intraocular surgery, other than cataract surgery.\n\nIf two eyes satisfy the inclusion criteria, both eyes will be included in the study. If one eye satisfies the inclusion criteria, the eye that qualifies will be included in the study.",{"count":579,"type":23},2000,"This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.",[582,583,584,585,586,587,588,30,589,590,591,592,593,594,595],"Alzheimer's Disease","Mild Cognitive Impairment","Parkinson's Disease","Multiple Sclerosis","Huntington Disease","Lewy Body Dementia","Frontotemporal Dementia","APOE-4 Positive","Traumatic Brain Injury","Concussion","Post-Traumatic Stress Disorder","Down Syndrome","Neuro-Degenerative Disease","Normal Cognition",[597,598,599,600,601,602,603,604,605,606,607],"OCT angiography (OCTA)","Optical Coherence Tomography (OCT)","Vessel Density","Superficial Capillary Plexus","Retinal microvasculature","Scanning Laser Ophthalmoscopy","Ultra-widefield (UWF) Imaging","Perfusion Density","Retinal Nerve Fiber Layer","Ganglion Cell Inner Plexiform Layer","Choroidal Vascularity Index","2026-02-02",{"date":610,"type":35},"2026-02-04",{"date":612,"type":35},"2017-07-20",{"date":614,"type":23},"2026-12-31",{"name":303,"class":74},{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":621,"acronym":4,"eligibilityCriteria":622,"healthyVolunteers":311,"sex":18,"minAge":19,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":24,"phases":625,"briefSummary":626,"conditions":627,"keywords":630,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":642,"locationsCount":75},"100622175","quantification-of-hsp90-in-the-human-brain-100622175","NCT07380204","Quantification of Hsp90 in the Human Brain","In Vivo Quantification of Hsp90 in the Human Brain in Healthy Aging and Neurodegeneration Using the Novel PET Radioligand [11C]HSP990","Inclusion Criteria:\n\nHealthy controls\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n* Male or female subjects, age between 18-55 (Part 1, n = 3), 18-40 (Part II, n = 5) or 40-70 (Part III, 40-55 n = 5, 55-70 n = 5) years old.\n* Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.\n* No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment as described hereabove and neuropsychological assessment (SCL-90).\n* (Part II and III only: ) In subjects \\\u003C 60 years of age, a normal structural MRI scan as assessed by expert radiologist. In subjects \\>= 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) Fazekas score \\\u003C 2 on the Age-Related White Matter changes scale are acceptable\n\nParkinson's disease\n\n* Age 45-85 years.\n* Patient has clinically established PD based on the Movement Disorder Society (MDS) diagnostic criteria and is in Hoehn-Yahr stage I-III in the \"on\" medication state\n* Patient has had a previous abnormal DaT-scan confirming the clinical diagnosis.\n* Patient is able to understand the patient information brochure and give written informed consent\n\nAlzheimer's disease\n\n* Age 45-85 years.\n* MoCA score \\\u003C 26\n* Patient has a diagnosis of probable AD with evidence of the AD pathophysiological process (amyloid PET scan or CSF determination) according to the consensus criteria \\[McKahn et al 2011, Alzh Dement\\].\n* Patient is able to understand the patient information brochure and give written informed consent.\n\nAmyotrophic lateral sclerosis\n\n* Age 20-85 years.\n* Subjects will be recruited at the Neurology department of University Hospitals Leuven and must meet revised El Escorial Criteria and Awaji-Shima criteria for at least possible ALS.\n* Patient is able to understand the patient information brochure and give written informed consent.\n\nExclusion Criteria:\n\nHealthy controls\n\n* Participant has a history of any major disease that may interfere with the investigations or make the subject unfit for participation according to the interpretation by the investigator (especially diabetes mellitus, heart disease, liver and kidney disease, or most forms of cancer).\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial .\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device.\n* Evidence of cognitive impairment.\n* Subject has a history or evidence of psychiatric disease.\n* Subject has renal impairment with eGFR \\\u003C 60 ml\u002Fmin.\n* Subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.\n* (Part II and III only: ) Subject has a contra-indication for MRI scanning.\n* Subject has a known hypersensitivity to any of the excipients that are present in the radiopharmaceutical preparations or to any of the excipients listed in the IMPD for \\[11C\\]HSP990.\n* Subject suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures. Subject cannot lie still for at least 70 minutes inside a scanner.\n* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning;\n* Subject does not understand the study procedures.\n* Subject is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.\n* Subject is pregnant (according to Ulti Med hCG urine test) or is breastfeeding.\n* Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP: contraception methods with a relatively high Pearl index (natural methods, minipill outside postpartum period, spermicides or condoms in monocontraception or no usage of contraception when sexually active) are not accepted.\n* Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.\n* Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him\u002Fherself.\n* (Part II and III only: ) An abnormal Allen test or hypersensitivity\u002Fallergy to lidocaine.\n* (Part II and III only: ) Anticoagulant therapy is an exclusion criterium for undergoing arterial sampling as part of the study. Subjects that have anticoagulant therapy can participate in the study parts without arterial sampling.\n\nParkinson's disease:\n\n* Neuropsychiatric diseases other than the cohort inclusion condition\n* Major internal medical comorbidity, in particular diabetes or heart disease\n* Subject has renal impairment with eGFR \\\u003C 60 ml\u002Fmin.\n* White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities\n* History of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug use\n* Contraindications for MR\n* Subject has a known hypersensitivity to any of the excipients that are present in the radiopharmaceutical preparations or to any of the excipients listed in the IMPD for \\[11C\\]HSP990.\n* Subject suffers from claustrophobia or cannot tolerate confinement during PET scanning procedures; subject cannot lie still for 70 minutes inside the scanner.\n* Subject is unwilling to avoid unusual, unaccustomed, or strenuous physical activity (i.e., weightlifting, running, bicycling) from the time of the pre-study visit until the end of scanning.\n* Subject does not understand the study procedures or does not have a guardian who understands the study procedures.\n* Subject (or guardian) is unwilling or unable to perform all of the study procedures or is considered unsuitable in any way by the principal investigator.\n* Subject does not agree that incidental findings are communicated to the general practitioner and to the participant him\u002Fherself.\n* Subject is pregnant (according to Ulti Med hCG urine test) or breastfeeding.\n* Subject is a woman of childbearing potential who does not agree to apply appropriate contraception methods during study participation and continues to do so for at least 6 months after study completion. For WOCBP\\* : contraception methods with a relatively high Pearl index (natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active) are not accepted.\n* Subject is a man with a pregnant or non-pregnant WOCBP partner, who does not agree to use a condom and continue to do so until 90 days after study completion. In addition, the non-pregnant WOCBP partner should use a highly effective method of contraception.\n* Anticoagulant therapy is an exclusion criterium for undergoing arterial sampling as part of the study. Subjects that have anticoagulant therapy can participate in the study parts without arterial sampling.\n\nAlzheimer's disease:\n\n\\- cf. Parkinson's Disease exclusion criteria\n\nAmytorphic lateral sclerosis:\n\n* cf. Parkinson's Disease exclusion criteria\n* Subject has confined upper motor neuron involvement (i.e. primary lateral sclerosis) or confined lower motor neuron involvement (i.e. progressive muscular atrophy).","70 Years",{"count":336,"type":23},[54],"This study tests the radiolabeled molecule (\"tracer\"), \\[¹¹C\\]HSP990, using positron emission tomography (PET) imaging to assess whether it can be used to measure levels of Heat Shock Protein 90 (Hsp90). The protein Hsp90 plays an important role in how proteins in the brain fold into their three-dimensional structure and how this protein helps maintain cellular homeostasis. Since neurodegenerative diseases such as Alzheimer's disease (AD), Parkinson's disease (PD), and amyotrophic lateral sclerosis (ALS) are characterized by disrupted three-dimensional protein folding resulting in protein aggregation, we also aim to measure Hsp90 levels in patients with these conditions.\n\n\\[¹¹C\\]HSP990 is a promising tracer for this purpose and has already been extensively tested in animal models with safe and favorable results. The investigator now aims to evaluate this tracer in the human brain in healthy volunteers as well as in patients with Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis. The investigator expects that Hsp90 protein levels will be present at reduced concentrations in patients, possibly in different brain regions depending on the distribution of the disease-causing proteins associated with these disorders.\n\nSince the discovery of the important role of Hsp90 in neurodegenerative diseases, several candidate drugs targeting Hsp90 have been developed in recent years. The imaging method used in this study may support the development of Hsp90-targeting medications by enabling measurement of Hsp90 levels in the brain and assessment of the effects of these drugs.",[628,629,30],"Parkinson's Disease (PD)","Alzheimer's Disease (AD)",[631,632,633,634,635,636,62],"HSP90","PET","test-retest","dosimetry","Parkinson","Alzheimer",{"date":608,"type":35},{"date":639,"type":35},"2024-09-04",{"date":641,"type":23},"2027-12",{"name":643,"class":74},"Universitaire Ziekenhuizen KU Leuven",{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":311,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":236,"phases":4,"briefSummary":653,"conditions":654,"keywords":656,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":667,"locationsCount":98},"100613610","translating-single-cell-vulnerability-into-novel-als-biomarkers-and-therapeutic-targets-towards-a-liquid-nerve-biopsy-100613610","NCT07268833","Translating Single-cell Vulnerability Into Novel ALS Biomarkers and Therapeutic Targets: Towards a Liquid Nerve Biopsy","TUNEABLE","Inclusion Criteria for als patients:\n\n* Age equal or over 18 years old\n* ALS patients, diagnosed accordingly to the revised El Escorial Criteria\n* Disease duration \\\u003C24 months from symptom onset.\n\nExclusion Criteria for als patients:\n\n* FVC \\\u003C60%;\n* nutritional or respiratory failure;\n* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.\n\nInclusion criteria for ALS pre-symptomatic patients\n\n* Age equal or over 18 years old\n* Patients with genetic defined susceptibility to ALS and one or more strict relative affected from ALS Exclusion criteria for ALS pre-symptomatic patients\n* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.\n\nInclusion criteria for controls\n\n* Age equal or over 18 years old\n* Subjects without a diagnosis of neurodegenerative disease or neuromuscular disorder.\n\nExclusion criteria for controls\n\n• significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.\n\nInclusion criteria for non ALS neurodegenerative patients\n\n* Age equal or over 18 years old\n* For AD: Diagnosis according to 2018 NIA-AA Framework for Alzheimer's Disease\n* For FTD: Diagnosis according to 2011 International Behavioural Variant FTD Criteria Consortium\n* For PD: Diagnosis according to 2015 Movement Disorder Society criteria\n* For DLB: Diagnosis according to 2017 Fourth Consensus Report of the DLB Consortium Exclusion criteria for non ALS neurodegenerative patients\n* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.\n\nInclusion criteria for neuromuscular disease patients\n\n* Age equal or over 18 years old\n* Presence of axonal or demyelinating neuropathy Exclusion criteria for neuromuscular patients\n* significant hepatic or chronic renal failure or any interveninginfective or metabolic conditions potentially influencing CBs levels.",{"count":652,"type":23},400,"The progress of ALS research and clinical practice is hampered by lack of effective biomarkers to monitor disease onset and progression. In response to this urgent need, we will integrate single-cell system biology approaches, histopathological and clinical data from precious human nerve biopsies collected from living ALS patients during the diagnostic workup and findings from innovative preclinical mouse models to unmask cell-specific molecular alterations that arise in the PNS tissue during the course of ALS pathology. This information will be used to select protein biomarkers of dysfunctional states associated with pre-manifest or early symptomatic stages of the disease, which will be further screened and validated in patient biofluids. Altogether, this project will lead to the discovery of novel, reliable and specific ALS biomarkers while providing insights into ALS mechanisms by leveraging an original \"PNS perspective\" on disease pathogenesis.",[30,655],"Peripheral Neuropathies",[62,655,382,657,658,659,660,661],"Biomarkers","Neurodegeneration","Nerve Biopsy","skin biopsy","Spatial Transcriptomics",{"date":663,"type":35},"2025-12-08",{"date":665,"type":35},"2024-10-24",{"date":323,"type":23},{"name":668,"class":74},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta"]