[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-to-moderate-alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-to-moderate-alzheimers-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100653668","phase-2-a-28-day-study-of-gal-101-in-participants-with-mild-to-moderate-alzheimers-disease-100653668",false,"NCT07789873","A 28-Day Study of GAL-101 in Participants With Mild to Moderate Alzheimer's Disease","SAPHARY","Inclusion Criteria:\n\n* Male or female participants aged 50 to 85 years, inclusive.\n* Clinical diagnosis of Alzheimer's disease at the mild or moderate dementia stage (Stages 4 or 5) according to the 2018 National Institute on Aging and Alzheimer's Association criteria\n* Evidence of amyloid-beta pathology based on cerebrospinal fluid biomarkers, amyloid-beta positron emission tomography, or plasma phosphorylated tau 217.\n* Evidence of cognitive decline during the previous year.\n* Availability of a reliable trial partner, caregiver, or legal representative who has contact with the participant for at least 10 hours per week and can support study participation.\n* Able and willing to provide informed consent and comply with study requirements.\n* In sufficiently good health, in the investigator's opinion, to participate in the study.\n* If receiving an acetylcholinesterase inhibitor or memantine, treatment must be at a stable dose for the protocol-specified period.\n\nExclusion Criteria:\n\n* A neurological, psychiatric, cerebrovascular, or other medical condition that could explain the participant's cognitive impairment, interfere with study assessments, or create an unacceptable safety risk.\n* Previous treatment with anti-amyloid-beta immunotherapy.\n* Participation in another interventional clinical study or receipt of an investigational drug within 3 months before screening.\n* Use of prohibited medications or substances that could affect cognition, electroencephalography assessments, safety, or interpretation of the study results.\n* Clinically significant or unstable cardiovascular, respiratory, renal, hepatic, metabolic, infectious, or malignant disease.\n* Active major depression, schizophrenia, bipolar disorder, or clinically significant suicide risk.\n* Known or suspected hypersensitivity to GAL-101, placebo, or their components.\n* A scalp condition that would prevent adequate electroencephalography assessment.\n* Inability to comply with the study schedule or procedures.\n* Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.","ALL","50 Years","85 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2a study will evaluate the safety and tolerability of GAL-101 in approximately 100 participants with mild to moderate Alzheimer's disease associated with amyloid-beta pathology. Participants will be randomly assigned to receive either 1200 mg of GAL-101 salt or matching placebo tablets by mouth once daily for 28 days. Neither the participants nor the study team will know which treatment each participant receives during the study.\n\nThe study will also explore whether GAL-101 affects brain-wave activity measured using quantitative electroencephalography, Alzheimer's disease-related biomarkers in cerebrospinal fluid, and performance on cognitive tests. Blood and cerebrospinal fluid samples will be collected to evaluate how GAL-101 is absorbed and distributed in the body.",[27],"Mild to Moderate Alzheimer's Disease",[29,30,31,32,33,34,35,36,37,38],"GAL-101","Amyloid-Beta","Pathology Synaptic Plasticity","Quantitative Electroencephalography qEEG","Cerebrospinal Fluid Biomarkers","Neurogranin","SNAP-25","VAMP2","Cognitive Function","Pharmacokinetics","NOT_YET_RECRUITING","2026-08-24",{"date":42,"type":43},"2026-08-27","ACTUAL",{"date":45,"type":21},"2027-02-28",{"date":47,"type":21},"2028-07-31",{"name":49,"class":50},"Galimedix Therapeutics Inc","INDUSTRY",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100628091","phase-1-the-effect-of-cb-exo-a600-in-mild-to-moderate-alzheimers-disease-100628091","NCT07457125","The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease","The Safety and Preliminary Efficacy of Exosomes Derived From Umbilical Cord Mesenchymal Stem Cell (CB-Exo-A600) in Mild to Moderate Alzheimer's Disease","CB-EXOAD","Inclusion Criteria:\n\n* Age ≥ 50 years, male or female.\n* Clinical diagnosis of AD (mild to moderate stage, corresponding to clinical stage 4-5 at screening according to the 2024 National Institute on Aging\u002FAlzheimer's Association \\[NIA\u002FAA\\] criteria).\n* Patients with cerebrospinal fluid biomarker data supporting an AD diagnosis within the past 3 years, or a positive amyloid Positron Emission Tomography (PET) scan result within the past 3 years, or a plasma p-tau217 test result indicating brain amyloid positivity.\n* Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan performed within 6 months prior to screening shows findings consistent with the clinical diagnosis of mild to moderate AD and no other clinically significant comorbid pathologies, particularly cerebrovascular disease. If an MRI or CT scan is not available within the 6 months prior to screening, an MRI must be completed and results confirmed before the subject initiates treatment.\n* Modified Hachinski Ischemic Score (mHIS) ≤ 4.\n* Mini-Mental Status Examination (MMSE) score between 10 and 24 (inclusive).\n* The subject has a clearly identified and reliable caregiver who meets the following criteria: able to independently read and understand relevant study documents at the study site and communicate necessary information with the investigator; willing to comply with clinical study procedures and ensure the provision of accurate information regarding the subject's status throughout the study; resides with the subject or provides care for the subject for no less than 2 hours per day on at least 3 days per week.\n* Female subjects of childbearing potential (including women of reproductive age and those less than 1 year postmenopausal) must use effective contraceptive methods throughout the study.\n* Patients have been on stable doses of cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine, huperzine A), excitatory amino acid receptor antagonists (e.g., memantine), or other cognitive-enhancing medications (e.g., sodium oligomannate) for at least 60 days prior to enrollment and must continue on the same doses throughout the study period.\n* The subject or their legal guardian voluntarily signs a written informed consent form and is able to comply with the study requirements for dosing and follow-up.\n\nExclusion Criteria:\n\n* Patients with a known allergic reaction to the investigational drug or similar drugs.\n* Patients with a known allergic constitution.\n* Previous receipt of umbilical cord mesenchymal stem cell therapy.\n* Laboratory findings (any of the following): absolute neutrophil count \\\u003C 1.0 × 10⁹\u002FL, platelet count \\\u003C 100 × 10⁹\u002FL, serum creatinine \\> upper limit of normal range, serum total bilirubin, alanine aminotransferase, or aspartate aminotransferase \\> 2 × upper limit of normal range.\n* Contraindications for MRI, including but not limited to: presence of cardiac pacemaker, defibrillator, cardiac stent, artificial heart valve, post-aneurysm surgery metal clips, implanted drug infusion device, any implanted electronic device (nerve stimulator, bone growth stimulator), intravascular embolization coils, filters, ECG monitor, metal sutures, shrapnel or buckshot, fracture fixation hardware, cochlear implant, middle ear implant, intraocular metallic foreign body, etc.\n* Subject has Parkinson's disease, multiple cerebral infarction, vascular dementia, Huntington's disease, hydrocephalus, progressive supranuclear palsy, multiple sclerosis, epilepsy, intellectual disability, or a history of significant traumatic brain injury (with or without persistent neurological deficits) or known structural brain abnormalities.\n* Serious systemic infection within 3 months prior to the screening period.\n* Positive for Hepatitis B surface antigen, e antigen, or e antibody, or positive for Hepatitis B core antibody with detectable Hepatitis B virus DNA; positive for Hepatitis C virus antibody; positive for syphilis serology; or positive for Human Immunodeficiency Virus antibody.\n* History of alcohol abuse, drug abuse, or psychiatric illness within 10 years prior to screening.\n* History of malignant tumors.\n* Uncontrolled or poorly controlled cardiovascular, cerebrovascular, hepatic, renal, pulmonary, endocrine or other systemic diseases.\n* Presence of severe aphasia, auditory\u002Fvisual impairment, unstable cardiac arrhythmia, or other severe conditions that would preclude completion of cognitive assessments or receipt of treatment.\n* Any other severe, advanced, or end-stage disease with a life expectancy of less than 12 months.\n* Known pregnancy or breastfeeding, or positive pregnancy test prior to randomization.\n* Current participation in another interventional clinical study that may interfere with outcome assessments.\n* Any other condition deemed by the investigator to make the subject unsuitable for participation or that may pose a significant risk to the patient.",{"count":60,"type":21},33,[62,24],"PHASE1","This study is divided into two phases: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is a single-center study, while the expansion cohort phase is a multicenter, prospective, randomized, double-blind, placebo-controlled study.",[27],[66],"Exosomes","RECRUITING","2026-05-19",{"date":70,"type":43},"2026-05-22",{"date":72,"type":21},"2026-05-30",{"date":74,"type":21},"2028-12-30",{"name":76,"class":77},"Xuanwu Hospital, Beijing","OTHER",1]