[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyloid-plaque\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyloid-plaque":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"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":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":15,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":67,"conditions":68,"keywords":73,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":4},"100529688","NCT06177028","MCLENA-2: A Phase II Clinical Trial for the Assessment of Lenalidomide in Patients With Mild Cognitive Impairment","MCLENA-2: A Phase II Clinical Trial for the Assessment of Biomarker Trajectory in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease Treated With Lenalidomide (Amendment to IND # 142121)","In order to be eligible for this study, subjects must meet the following inclusion criteria:\n\nInclusion Criteria:\n\n1. Male or female outpatients.\n2. At least 50 years of age, but less than 90 (89 at time of screening)\n3. Females must be surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).\n4. Must have been diagnosed with amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e. at both the screening and baseline visits (visits 1 and 2) have a documented Mini Mental State Exam (MMSE) score between 22-28.\n5. CT or MRI scan of the brain obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or of pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.\n6. Vision and hearing must be sufficient to comply with study procedures.\n7. Be able to take oral medications.\n8. Hachinski ischemic score must be ≤ 4.\n9. Geriatric depression scale must be ≤ 10.\n10. Can be on stable doses of a cholinesterase inhibitor and\u002For memantine as long as it is stable for at least 90 days before screening and is expected to remain on a stable dose for the remainder of the study period; or have demonstrated intolerance to or lack of efficacy from these medications.\n11. Must have a collateral informant\u002Fstudy partner who has significant direct contact with the patient at least 10 hours per week and who is willing to accompany the patient to specified clinic visits, supervise administration of all study medication, and be available for telephone visits\u002Finterviews.\n12. If the patient has a legally authorized representative (LAR), the LAR must review and sign the informed consent form. If the patient does not have an LAR, the patient must appear able to provide informed consent and must review and sign the informed consent form. In addition, the patient's informant\u002Fstudy partner (as defined above) must sign an informed consent form. If the LAR and the patient's informant \u002Fstudy partner is the same individual, he\u002Fshe should sign under both designations.\n13. Must reside in the community.\n14. Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.\n15. Positivity for amyloid brain scan: Amyloid PET positive at SUVr of 1.05\n\nExclusion Criteria:\n\nSubjects will be excluded if they have any of the condition listed below:\n\n1. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, head injury with loss of consciousness\n2. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.\n3. Unwilling or unable to undergo a Lumbar Puncture.\n4. Known history or self-reported alcohol or substance abuse.\n5. Living alone.\n6. Poorly controlled hypertension. 7 .History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure\u002Fangioplasty).\n\n8\\. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.\n\n9\\. Untreated sleep apnea. 10. Any thyroid disease (unless euthyroid on treatment for at least 6 months prior to screening).\n\n11\\. Active neoplastic disease (except for skin tumors other than melanoma) within five years.\n\n12\\. History of multiple myeloma. 13. Absolute neutropenia of \\\u003C750\u002Fmm3, or a history of neutropenia. 14. History of or current thromboembolism (including deep venous thrombosis). 15. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C antigen\u002Fantibody or an elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN).\n\n16\\. Clinically significant hematologic or coagulation disorder including any unexplained anemia or a platelet count less than 100,000\u002FμL at screening.\n\n17\\. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.\n\n18\\. Use any investigational medical device within two weeks before screening or after end of the present study.\n\n19\\. Females who are at risk of pregnancy or are of child bearing age. 20. Unwilling or unable to undergo MRI and PET imaging. 21. Cardiac pacemaker or defibrillator or other implanted device. 22. In the opinion of the investigator, participation would not be in the best interest of the subject",true,"50 Years","90 Years",{"count":65,"type":20},45,[24],"This is a randomized, double-blind, placebo-controlled, parallel group study. The use of placebo is appropriate to minimize bias related to treatment expectations of the subject, study partner, and site investigator, as well as to changes in the relationship between the subject and study partner that might occur with the initiation of treatment and expectation of improvement in motor symptoms or cognition. Changes in subject\u002Fstudy partner interactions can impact subject mood and might introduce biases that cannot be quantified. The double-blind use of placebo will also prevent bias in the clinical and scientific assessments.",[69,70,27,71,72],"Cognitive Impairment, Mild","Cognitive Dysfunction","Neurodegenerative Disease, Hereditary","Inflammation, Brain",[41,74,75,76,77,78,79],"CSF","Biomarkers","Brain Imaging","Brain Amyloid","Memory Loss","Immunomodulation","NOT_YET_RECRUITING","2025-05-14",{"date":83,"type":46},"2025-05-18",{"date":85,"type":20},"2025-06-01",{"date":87,"type":20},"2027-01-02",{"name":89,"class":90},"St. Joseph's Hospital and Medical Center, Phoenix","OTHER",""]