[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parkinsonian-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parkinsonian-disorders":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,90,142,171,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100648248","phase-1-zr001-chemogenetics-gene-therapy-study-in-patients-with-parkinsons-disease-100648248",false,"NCT07718659","ZR001 Chemogenetics Gene Therapy Study in Patients With Parkinson's Disease","An Open-label, Single Arm, Dose-Escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ZR001, a Gene Therapy Based on Chemogenetics, for the Treatment of Parkinson's Disease","Inclusion Criteria:\n\n* Participants who meet all of the following criteria are eligible for enrollment:\n\n  1. Age ≥40 and ≤70 years (at the time of signing the informed consent), any gender.\n  2. Diagnosed with Parkinson's disease according to the Diagnostic Criteria for Parkinson's Disease in China (2016 edition).\n  3. Modified Hoehn \\& Yahr stage between 2.5 and 4.\n  4. History of Parkinson's disease for at least 5 years but less than 15 years.\n  5. Moderate to severe MDS-UPDRS Part III score in the off period, and improvement rate ≥30% after acute levodopa stress test.\n  6. Clinically stable symptoms and stable types and doses of anti-Parkinsonian medications within 3 months prior to enrollment.\n  7. Agree to provide biological samples required for the study (e.g., blood, urine).\n  8. Consent to hospitalization for intraparenchymal drug injection surgery.\n  9. Male or female participants of childbearing potential agree to use effective contraceptive methods (oral contraceptives are prohibited) from the time of signing the informed consent until at least 6 months after discontinuing clozapine.\n  10. Participants or their stable caregivers are able to understand and willing to comply with the study requirements and procedures, voluntarily participate, and sign the informed consent. If a caregiver is present, they must accompany the participant to study visits and assist the investigator in completing relevant scale assessments.\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria will be excluded from this study:\n\n  1. Have participated in or are currently participating in other clinical studies of PD drugs or other AAV gene therapy or cell therapy.\n  2. Presence of other severe psychiatric disorders (e.g., severe depression, schizophrenia, etc.).\n  3. Previous adverse reactions to clozapine, such as agranulocytosis or severe neutropenia.\n  4. Participants with known allergic constitution, including allergy or hypersensitivity to clozapine, prednisone acetate, other glucocorticoids, their excipients, or local anesthetics.\n  5. History of alcohol or drug abuse within the past 2 years.\n  6. Participants requiring invasive or non-invasive ventilatory support.\n  7. Serum AAV binding antibody titer \\>1:2000.\n  8. Presence of clinically significant laboratory abnormalities as assessed by the investigator: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin; creatinine, hemoglobin (Hb), prothrombin time (PT), activated partial thromboplastin time (APTT), fasting blood glucose, platelets (PLT).\n  9. Presence of liver disease, heart disease, kidney disease or history thereof, which, in the investigator's assessment, may pose surgical or drug-related risks to the participant.\n  10. Suffering from autoimmune diseases or immunocompromised status requiring hormone or immunosuppressive therapy, which, in the investigator's assessment, may pose surgical or drug-related risks.\n  11. Suffering from other severe systemic diseases (e.g., cor pulmonale, moderate-to-severe asthma, etc.) that, in the investigator's assessment, may pose surgical or drug-related risks.\n  12. In the investigator's assessment, the participant has contraindications to anesthesia or surgery and is unsuitable for intraparenchymal administration, or other special circumstances.\n  13. Positive for human immunodeficiency virus antibody, hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, active TORCH virus infection, or active Epstein-Barr virus infection.\n  14. Concomitant use of any of the following medications within 90 days prior to administration, or planned immunosuppressive therapy (cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, rituximab) within 6 months after start of the trial, except for prophylactic medications specified in the protocol.\n  15. Pregnant or breastfeeding women, or those planning to become pregnant.\n  16. Other conditions that, in the investigator's opinion, make the participant unsuitable for participation in this study.","ALL","40 Years","70 Years",{"count":20,"type":21},8,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study aims to evaluate the safety, tolerability, and preliminary efficacy of ZR001, a novel chemogenetic gene therapy product, in patients with moderately advanced Parkinson's disease (PD). ZR001 is administered via stereotactic injection into the bilateral substantia nigra, followed by postoperative ultra-low-dose clozapine to activate the transduced direct pathway, with the goal of improving motor symptoms of Parkinson's disease.",[27,28],"Parkinson's Disease (PD)","Parkinsonian Disorders",[30,31,32,33,34,35,36,37,38,39,40],"AAV","DREADD","PD","D1-MSN","Gene Therapy","Chemogenetics","Parkinson's Disease","Clozapine","Central Nervous System Diseases","Movement Disorders","Neurodegenerative Diseases","NOT_YET_RECRUITING","2026-07-17",{"date":44,"type":45},"2026-07-22","ACTUAL",{"date":47,"type":21},"2026-12-01",{"date":49,"type":21},"2030-12-01",{"name":51,"class":52},"Qianfoshan Hospital","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":53},"100607383","study-of-axial-and-cognitive-symptoms-and-biomarkers-of-neurodegeneration-in-brain-first-and-body-first-pd-100607383","NCT07187843","Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD","Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes","BRABOAXPD","Inclusion Criteria:\n\n* Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy \\[123I-MIBG\\].\n* Free and informed consent expressed by the participant.\n* At least 18 years of age.\n\nExclusion Criteria:\n\n* Inability to express free and informed consent.\n* Patient with a doubtful diagnosis.\n* Participant under 18 years of age.","18 Years",{"count":64,"type":21},150,"OBSERVATIONAL","This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed \"Brain-First\" and \"Body-First\" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.\n\nFindings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.",[68,28,69,70,71],"Parkinson Disease","Brain Disease","Basal Ganglia Diseases","Synucleinopathies",[40,73,39,74,75,76,77,78],"Nervous System Diseases","biomarker","neuroinflammation","brain-first","body-first","axial symptoms","RECRUITING","2026-04-22",{"date":82,"type":45},"2026-04-23",{"date":84,"type":45},"2024-09-04",{"date":86,"type":21},"2031-05",{"name":88,"class":89},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":16,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":53},"100617877","slowing-cognitive-decline-in-alpha-synucleinopathies-by-enhancing-physical-activity-100617877","NCT07324330","Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity","ALPHA-FIT","Inclusion Criteria:\n\niRBD:\n\n* Age: 50-80 years\n* Polysomnographically confirmed diagnosis of iRBD\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nHealthy controls:\n\n* Age: 50-80 years\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nExclusion Criteria:\n\niRBD:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n\nHealthy controls:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n* clinically diagnosed iRBD",true,"50 Years","80 Years",{"count":101,"type":21},130,[103],"NA","α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.\n\nThe aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.\n\nEighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the \"Deutsches Zentrum für Neurodegenerative Erkrankungen\" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.",[68,106,40,70,38,71,73,107,108,28],"Prodromal Stage","Cerebral Disorder","Brain Diseases",[110,111,112,113,114,115,74,116,117,118,119,120,121,122,123,124,125,126,127,32,128,129,130,131,132],"intervention","movement","iRBD","prodromal parkinson's","non-pharmacologic","alpha-synucleinopathy","cognitive decline","executive function","MRI","lifestyle","prevention","RCT","motor decline","smartphone","smartwatch","accelerometer","scalable","prodromal","Parkinson","Lewy-body","MSA","multiple system atrophy","dementia","2026-01-14",{"date":135,"type":45},"2026-01-16",{"date":137,"type":45},"2025-12-04",{"date":139,"type":21},"2029-12-01",{"name":141,"class":52},"University Hospital, Bonn",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":97,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":150,"targetDuration":152,"studyType":65,"phases":4,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":170},"100335598","the-national-registry-study-for-the-real-world-patients-with-parkinsonian-disorders-in-china-100335598","NCT03649503","The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China","The National Registry Study For the Real-world Patients With Parkinsonian Disorders in China (ForPDCN)","ForPDCN","Inclusion Criteria:\n\nAnyone with Parkinsonian Disorders is welcome to join the Registry.\n\nExclusion Criteria:",{"count":151,"type":21},100000,"10 Years","The overall goal of this project is to identify, assess and longitudinally monitor subjects who are interested in participating in this study. Participants will enroll through a platform named PaWei, and provide informed consent prior to any study activities. PaWei will collect a variety of information, including participants' demographic information, overall health, family history of Parkinson's Disease, other clinical information (clinical drug use, drug efficacy, and comorbid disorders), mood status, sleep, diet, exercise, memory complaints, online cognitive tests, the Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8), Movement Disorder Society-Unified Parkinson's Disease Rating Scale IB \\& II (MDS-UPDRS IB \\& II), Non-Motor Symptom Aassessment Scale for Parkinson's Disease (NMSS) , Hoehn and Yahr Scale, and other scales related to quality of life, etal---all through self-reported online questionnaires. Participants will also be asked to return to the PaWei every 3 months at regular intervals, to complete follow-up scales related to quality of life, and neuropsychological assessments, etal. Anyone with Parkinsonian Disorders is welcome to participate.",[28],[156,157,158,159,160],"Brain Health","Brain Research","parkinsonism","prospective cohort study","large sample size","2025-09-29",{"date":163,"type":45},"2025-10-02",{"date":165,"type":45},"2018-10-01",{"date":167,"type":21},"2033-09-30",{"name":169,"class":52},"Huashan Hospital",2,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":170},"100592416","slow-speed-slowing-parkinsons-early-through-exercise-dosage-100592416","NCT06993142","Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage","Slow-SPEED","Inclusion criteria\n\n1. previously identified LRRK2 G2019S or GBA N370S variant based on genotyping\n2. aged 50 years or older\n3. able to understand the English language\n4. being able to walk independently inside the home without the use of a walking aid\n5. in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer)\n6. Not in a high physical activity range during the 4-week eligibility and baseline period\n\nExclusion criteria\n\n1. clinically diagnosed or self-reported diagnosis neurodegenerative disease\n2. self-reported falls of three or more per year\n3. dexterity problems or cognitive impairments hampering smartphone use\n4. if they are not aware of and do not wish to be informed about an increased risk of developing diseases associated with the LRRK2 or GBA1 risk variant\n5. if individual is not community-dwelling\n6. in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)",{"count":179,"type":21},600,[103],"The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation.\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, the investigators aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[68,106,40,70,38,71,73,107,108,28,183],"Genetic Predisposition",[185,186,187,188,189,190,191,192,193,68,194,195,196,197,198],"Physical activity","Prevention","Remote","Mobile Health (mHealth)","Feasibility","Exercise","Digital biomarker","Motivational application","Walking","Prodromal","LRRK2","GBA1","Genetic","Smartwatch","2025-05-28",{"date":201,"type":45},"2025-06-03",{"date":203,"type":21},"2025-07-01",{"date":205,"type":21},"2029-06-30",{"name":207,"class":52},"Radboud University Medical Center",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":98,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":53},"100530935","slow-speed-nl-slowing-parkinsons-early-through-exercise-dosage-netherlands-100530935","NCT06193252","Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands","Slow-SPEED-NL","Inclusion Criteria:\n\n* previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)\n* able to understand the Dutch language\n* being able to walk independently inside the home without the use of a walking aid\n* Not in a high physical activity range during the 4-week eligibility and baseline period\n* in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.\n\nExclusion Criteria:\n\n* clinically diagnosed or self-reported diagnosis neurodegenerative disease;\n* self-reported weekly falls in the previous 3 months;\n* dexterity problems or cognitive impairments hampering smartphone use;\n* if they do not wish to be informed about an increased risk of developing diseases associated with iRBD\n* if individual is not community-dwelling\n\nExclusion criteria for MRI only:\n\n* history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery\n* claustrophobia\n* implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)\n* metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters\n* pregnancy\n* fear for incidental finding",{"count":216,"type":21},110,[103],"The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months).\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[68,106,40,28,220,70,38,71,73,107,108],"REM Sleep Behavior Disorder",[222,186,187,188,189,190,191,223,224,118,192,193,68,194],"Physical Activity","Blood","Imaging",{"date":201,"type":45},{"date":227,"type":45},"2024-01-15",{"date":229,"type":21},"2027-12-01",{"name":207,"class":52}]