[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prodromal-alzheimers-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prodromal-alzheimers-disease":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,87,112],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100474761",false,"NCT05462106","A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)","A Phase 1b\u002F2, Multicenter, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-24.060 in Subjects With Prodromal Alzheimer's Disease and in Adults With Down Syndrome (ABATE)","Inclusion Criteria:\n\nStudy Part 1a and Part 1b\n\n1. Age ≥50 and ≤85 years at screening.\n2. Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria.\n3. PET scan at screening consistent with the presence of amyloid pathology.\n4. Clinical Dementia Rating (CDR)-Global Score of 0.5.\n5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor (ACHEI) and\u002For memantine for at least 2 months prior to screening.\n\nStudy Part 2\n\n1. Age ≥35 and ≤50 years at screening (subjects with DS with age ≥35 and ≤39 years may be considered on the condition that there is prior evidence of amyloid results compatible with AD pathology at PET-scan and\u002For in biofluids).\n2. Male or female subjects with DS with a cytogenetic diagnosis being either trisomy 21 or complete unbalanced translocation of chromosome 21.\n3. PET scan at screening consistent with the presence of amyloid pathology.\n4. Mild to moderate intellectual disability as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification.\n5. Subjects must have a study partner who has direct and regular contact, at least 10 hours per week, with the subject and who is able to provide reliable answers to questions related to the subject, according to the study investigator.\n\nExclusion Criteria:\n\n1. Any unstable and\u002For clinically significant medical condition likely to hamper the evaluation of safety and\u002For efficacy of the study treatment (eg, moderate and\u002For severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.\n2. DSM-5 criteria for substance use disorders drug or alcohol abuse or dependence (with the exception of tobacco use disorder) currently met within the past 5 years.\n3. History or presence of uncontrolled seizures. If there is a history of seizures, they must be well controlled, with no occurrence of seizures in the 2 years before study screening. The use of antiepileptic medications is permitted.\n4. Concomitant or history of clinically significant and\u002For unstable psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and\u002For non-hemorrhagic stroke). Subjects with a history of major depressive disorder may be included if they have been free of major episodes for at least 1 year before screening.\n5. History of meningitis or meningoencephalitis.\n6. History of moderate or severe traumatic brain injury.\n7. History or presence of inflammatory neurological disorders.\n8. History or presence of immunological or autoimmune disorders.\n9. History of severe allergic reaction (eg, anaphylaxis) including, but not limited to severe allergic reaction to previous vaccines, foods, and\u002For medications.\n10. Significant risk of suicide, defined using the C-SSRS as the subject answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 12 months.\n11. MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or evidence of a previous macro-hemorrhage or showing more than 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as \"possible\" or \"definite\"). Evidence of space occupying lesions other than benign meningioma of less than 1 cm diameter, more than 2 lacunar infarcts, or 1 single infarct larger than 1 cm in diameter. Screening MRI scan showing structural evidence of alternative pathology not consistent with AD and is considered to be at the origin of subject's symptoms.\n12. Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.\n13. Subjects with a positive Human Immunodeficiency Virus (HIV-1 and 2) test at screening.\n14. Subjects with clinical or laboratory evidence of active hepatitis B or C at screening (eg, HBV or HCV antigens).\n15. Subjects with positive syphilis serology consistent with active syphilis at screening.\n16. Subjects with presence of antibody titers related to immunological or autoimmune disorders at screening.\n17. MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI and\u002For severe claustrophobia.\n18. Any contraindication for PET scan imaging.\n19. Any contraindication to lumbar puncture in subjects undergoing this procedure (note: lumbar puncture is optional in subjects with DS).\n20. Previous treatment with ACI-24 or any other active immunotherapy against AD at any time in the past unless there is firm evidence that the subject received placebo only and the placebo formulation is not expected to induce any specific immune response.\n21. Previous treatment with any investigational and\u002For marketed passive immunotherapy against AD within 6 months before screening or 5 half-lives, whichever is longer, unless there is firm evidence that the subject received placebo only.\n22. Ongoing treatment with any approved anti-amyloid passive immunotherapy for Alzheimer's disease.\n23. Use of acetylcholinesterase inhibitor or glutamatergic drugs (eg, memantine, topiramate, lamotrigine) if not on stable dose for at least 2 months before screening.\n24. Any vaccine, either live or not, including but not limited to influenza or COVID-19 vaccine, received within 4 weeks before randomization.\n25. Subjects with treated hypothyroidism not on a stable dose of replacement medication for at least 2 months before screening and having clinically significant abnormal serum T4 and\u002For thyroid stimulating hormone at screening.\n26. Subjects undergoing lumbar puncture and being treated with any anticoagulants or antiplatelet drugs, except aspirin at doses of 100 mg daily or lower.\n27. Use of antidepressants (other than selective serotonin reuptake inhibitors\u002Fserotonin-norepinephrine reuptake inhibitors at stable dose); typical antipsychotics; γ-aminobutyric acid agonists (eg, gabapentin); or stimulants (eg, methylphenidate, modafinil). Stable doses of atypical antipsychotics or benzodiazepines are only allowed if this is not considered to influence the safety and the efficacy of the study treatment according to the site investigator and the sponsor medical monitor.\n28. Chronic use of opioid analgesics. A limited treatment duration for acute conditions until 24 hours before cognitive assessment is allowed.\n29. Current use of immunosuppressant or immunomodulating drugs or their use within the 6 months before study screening. Current use of oral steroids or their use within the 3 months before study screening.\n\n    Additional Exclusion Criteria in Study Part 2\n\n    The following are exclusion criteria at the time of randomization but will not be considered as exclusionary after treatment assignment:\n30. Clinical diagnosis of AD dementia in DS as per International Classification of Diseases 10 (ICD-10).\n31. DSQIID \\>20.\n32. Intelligence quotient score \\\u003C40 (KBIT-2).","ALL","35 Years","85 Years",{"count":19,"type":20},304,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.",[27,28,29,30,31],"Amyloid Plaque","Beta-Amyloid","DSAD","Prodromal Alzheimer's Disease","Alzheimer's Disease",[33,34,35,27,28,36,37,38,39,40,29,41],"Dementia","Brain Diseases","Central Nervous System Diseases","Down syndrome","Immunogenicity","active immunotherapy","immune response","anti-amyloid therapy","Alzheimer's disease","RECRUITING","2026-05-27",{"date":45,"type":46},"2026-05-29","ACTUAL",{"date":48,"type":46},"2022-06-21",{"date":50,"type":20},"2029-04",{"name":52,"class":53},"AC Immune SA","INDUSTRY",26,{"id":56,"slug":4,"hasResults":10,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":10,"sex":15,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":4},"100605856","NCT07167966","Alzheimer's Tau Platform: Regimen A - AADvac1","Alzheimer's Tau Platform (ATP): Regimen Specific Appendix for AADvac1","ATP","Inclusion Criteria:\n\n* No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT06957418).\n\nExclusion Criteria:\n\n* No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol (NCT06957418).","50 Years","80 Years",{"count":65,"type":20},450,[24],"The Alzheimer's Tau Platform (ATP) is a multi-center platform trial to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.\n\nRegimen A will evaluate the safety and efficacy of AADvac1, alone or in combination with donanemab.",[69,30,70],"Preclinical Alzheimer's Disease","Alzheimer Disease",[72,73,74,75],"anti-amyloid mAb","monoclonal antibody (mAB)","tau","amyloid","NOT_YET_RECRUITING","2026-03-31",{"date":79,"type":46},"2026-04-06",{"date":81,"type":20},"2026-06-30",{"date":83,"type":20},"2028-08-31",{"name":85,"class":86},"Paul S. Aisen","OTHER",{"id":88,"slug":4,"hasResults":10,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":60,"eligibilityCriteria":92,"healthyVolunteers":10,"sex":15,"minAge":62,"maxAge":63,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":110,"leadSponsor":111,"locationsCount":4},"100589669","NCT06957418","Alzheimer's Tau Platform: Master Protocol","The Alzheimer's Disease Tau Platform Clinical Trial","Inclusion Criteria:\n\n1. Documentation of the participant's informed consent to study procedures (including APOE genotyping).\n2. Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB \\\u003C1.5\n3. Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \\\u003C1.5).\n4. MMSE score at screening of 20-30 (inclusive) with educational adjustments:\n\n   1. If \\\u003C12 years of education, MMSE required to be \\>20.\n   2. If 13 to 15 years (inclusive) of education, MMSE required to be \\>22.\n   3. If \\>16 years of education, MMSE required to be \\>24.\n5. Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD.\n6. Elevated brain tau on PET (MTL or NEO tau SUVr \\>1.2) at screening.\n7. Elevated brain amyloid on PET (centiloids \\> 40) at screening.\n8. Stable doses of permitted medications as described per protocol for a minimum of 30 days prior to screening.\n9. Resides at home or in the community (assisted living acceptable).\n10. In the opinion of the site PI, has a study partner able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week) for the duration of the study.\n11. As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish) sufficient for compliance with the required testing procedures.\n12. Must complete all screening evaluations as outlined per protocol.\n\nExclusion Criteria:\n\n1. Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.\n2. Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and\u002For are not willing to use highly effective method of contraception for the duration of their participation in the study. Males who are sexually active with a female of childbearing potential and do not agree to use barrier methods of contraception (condoms with spermicide) during the trial and for 6 months after the last dose of study drug unless the female is using a highly effective method of contraception.\n3. Lacks good venous access such that multiple blood draws would be precluded.\n4. Weighs less than 40kg, or more than 136kg at screening.\n5. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen.\n6. Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received placebo in the previous study.\n7. Prior or current treatment with a prohibited medication as described per protocol.\n8. Enrollment in another investigational study as described per protocol. Participants enrolled in an observational study may be permitted with Medical Monitor review and approval.\n9. Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and\u002For severe claustrophobia.\n10. MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or showing more than four (4) cerebral microhemorrhages (defined as 10 mm or less at the greatest diameter); evidence of a prior or current macrohemorrhage (greater than 10 mm at greatest diameter, also referred to as intracerebral hemorrhage \\>1 cm within this protocol); cerebral contusion; encephalomalacia; aneurysms greater than 6 mm, or any aneurysms that have not been stable in size for the past 2 years; vascular malformations that are at high risk for hemorrhage; infectious lesions; evidence of multiple lacunar infarcts (that in the opinion of the investigator, may impact cognition); stroke involving a major vascular territory; severe small vessel disease; severe diffuse white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).\n11. Contraindications to tau and\u002For amyloid PET scan imaging and\u002For use of MK6240 and\u002For 18F-NAV-4694 (flutafuranol).\n12. For participants undergoing an LP as part of the optional longitudinal CSF biomarker sub-study, contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; international normalized ratio (INR) \\>1.4 or other coagulopathy; platelet count of \\\u003C120,000\u002FμL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of LP NOTE: low dose aspirin is permitted; degenerative arthritis of the lumbar spine; suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.\n13. Any unstable and\u002For clinically significant medical condition likely to hamper the evaluation of safety and\u002For efficacy of study drug (e.g., moderate and\u002For severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per the site PI's judgement.\n14. History of severe allergic reaction (e.g., anaphylaxis) including, but not limited to: severe allergic reaction to previous vaccines, foods, and\u002For medications.\n15. Hospitalization within 30 days prior to screening or baseline.\n16. Clinically significant infections or major surgical operation within 3 months prior to screening.\n17. History of chronic or recurrent infections judged to be clinically significant by the site PI and which would potentially hamper the evaluation of efficacy and safety assessments.\n18. Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, or significant coronary artery disease.\n19. History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer, which have been fully removed and are considered cured.\n20. History of inflammatory neurological disorders.\n21. History or presence of immunological or inflammatory conditions, including neurological disorders, judged to be clinically significant by the site PI.\n22. History of meningitis or meningoencephalitis.\n23. History of moderate or severe traumatic brain injury.\n24. History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years prior to study screening. The use of antiepileptic medications is permitted (see section 6.5.2).\n25. Concomitant or past history of psychiatric or neurologic disorder other than those considered to be related to AD (e.g., head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and\u002For non-hemorrhagic stroke).\n26. DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.\n27. Significant risk of suicide defined, using the C-SSRS, as the participant answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 6 months.\n28. Clinically significant abnormal vital signs including sustained sitting blood pressure \\>160\u002F90 mm Hg.\n29. Participants with diabetes mellitus with hemoglobin A1c (HbA1c) levels of \\>7.5%.\n30. In the opinion of the site PI, clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, including, but not limited to:\n\n    1. hematocrit less than 35% for those with male biological sex and less than 32% for those with female biological sex.\n    2. absolute neutrophil cell count \\\u003C1500\u002FuL (with the exception of a chronic benign neutropenia).\n    3. absolute lymphocyte count \\\u003C900\u002FuL.\n    4. platelet cell count of \\\u003C100,000\u002FuL.\n    5. INR \\>1.4 or other coagulopathy, confirmed by repeat (not applicable for participants on anticoagulation).\n31. Participants with a known history of human immunodeficiency virus infection (HIV-1 and 2).\n32. Participants with known history of acute\u002Fchronic hepatitis B or C.\n33. Any other clinically significant, advanced, or unstable disease that may interfere with outcome evaluations, such as:\n\n    1. Chronic liver disease.\n    2. Respiratory insufficiency.\n    3. Renal insufficiency defined as estimated glomerular filtration rate (eGFR) \\\u003C50 mL\u002Fmin based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.\n    4. Bradycardia (\\\u003C50\u002Fmin) or tachycardia (\\>100\u002Fmin). Bradycardia \\>40\u002Fmin and \\\u003C50\u002Fmin may be permitted with review and approval by the Medical Monitor.\n34. Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening (minor abnormalities documented as clinically insignificant by the site PI are allowed).\n35. Any condition, which in the opinion of the site PI, Coordinating Center, or Project Lead\u002FProtocol PI, makes the participant unsuitable for inclusion.",{"count":94,"type":20},900,[24],"The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.\n\nThis platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen.\n\nThe main questions the platform trial aims to answer are:\n\n* Does a tau-directed therapy, alone or in combination with donanemab, reduce tau buildup in the brain compared to donanemab alone?\n* Does a tau-directed therapy, alone or in combination with donanemab, slow disease progression based on brain imaging, fluid biomarkers, and measures of memory and thinking?\n\nParticipants will:\n\n* Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time.\n* Receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab.\n* Undergo regular cognitive testing, brain scans (MRI\u002FPET), and biomarker assessments over 30 months\n\nParticipants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of donanemab and tau therapy, or (3) donanemab alone.\n\nNew regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available.\n\nATP will launch with one regimen: Regimen A: AADvac1. In the future, Regimen B (\"Tau2\") will launch with a second tau directed therapy.",[69,70,30],[41,99,100,101,102,33,103,104,105,106,107,72],"Preclinical Alzheimer's","Prodromal Alzheimer's","Mild cognitive impairment (MCI)","Neurodegeneration","Tau-directed therapy","Monoclonal antibody","Anti-tau therapy","Combination therapy","Immunotherapy",{"date":79,"type":46},{"date":81,"type":20},{"date":83,"type":20},{"name":85,"class":86},{"id":113,"slug":4,"hasResults":10,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":15,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100511034","NCT05934188","Exploring the Gut-Brain Axis in Ageing and Neurodegeneration","Role of the Gut-microbiota on Ageing and Neurodegeneration: a Clinical and Brain Imaging Study","GutBrain","INCLUSION CRITERIA:\n\nHealthy Young and Old Subjects:\n\n* 20-50 or 60-90 years old\n* Cognitively healthy (Mini-Mental State examination ≥ 26)\n* Absence of significant neurological disorders\n\nPatients with prodromal Alzheimer's Disease:\n\n* Subjective cognitive complaint (corroborated by the informant)\n* Episodic memory deficit on neuropsychological testing\n* Clinical Dementia Rating = 0.5\n* Mini-Mental State Examination (MMSE) \\> 23\n* Independently functioning in activities of daily living\n\nPatients with Parkinson's Disease:\n\n* Recent diagnosis of Parkinson's Disease\n* Mild-moderate score at the Unified Parkinson's Disease Rating Scale (UPDRS)\n* Cognitively healthy (Mini-Mental State examination ≥ 26)\n* In case of taking medications for Parkinson's Disease: stable dosage for at least 6 months\n\nPatients with Multiple Sclerosis:\n\n* Recent diagnosis of relapsing-remitting Multiple Sclerosis\n* Expanded Disability Status Scale score ≤ 4.0\n* Cognitively healthy (Mini-Mental State examination ≥ 26)\n* In case of taking medications for Multiple Sclerosis: stable dosage for at least 6 months.\n\nEXCLUSION CRITERIA:\n\nFor both healthy participants and patients:\n\n* Contraindications to magnetic resonance imaging (metal implant in body, known claustrophobia, pacemakers)\n* Severe comorbidities\n* Antibiotics treatments over the last 3 months",true,"20 Years","90 Years",{"count":123,"type":20},200,"OBSERVATIONAL","Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear.\n\nThe goal of this observational study is to characterise the gut-microbiota composition associated with alterations in brain structure and function during the ageing process and across neurodegenerative disorders. This is based on recent studies showing that changes in the human brain and in the microbiota composition, can indicate very sensitively and in a predictive way pathological development and, consequently, be used as markers of neurodegenerative diseases.\n\nThe main questions it aims to answer are:\n\n* How variation in the gut-microbiota composition correlates with the normal brain ageing trajectory?\n* How dysregulation in the gut-microbiota correlates with pathological changes in brain regions in specific neurodegenerative disorders?\n* Can the impact of the gut-microbiota on the brain be modulated by blood biomarkers?\n\nThe investigators will recruit 40 young healthy participants, 40 old healthy participants, 40 participants with prodromal Alzheimer's Disease, 40 participants with Parkinson's Disease and 40 participants with Multiple Sclerosis.\n\nParticipants will undergo the following examinations:\n\n* Magnetic Resonance Imaging\n* Analysis of a stool sample\n* Analysis of a blood sample\n* Neuropsychological assessment\n* Questionnaires on eating habits",[127,30,128,129],"Healthy","Parkinson Disease","Multiple Sclerosis",[131,132,133,134,135,136,137],"MRI","Microbiota","Stool sample","Blood sample","Neuropsychological assessment","Neuroimaging","Biomarkers for brain disorders","2026-01-07",{"date":140,"type":46},"2026-01-09",{"date":142,"type":46},"2023-05-01",{"date":144,"type":20},"2027-04-30",{"name":146,"class":86},"IRCCS San Camillo, Venezia, Italy",3,""]