CTIS2023-507325-42-00招募中1 期
A Master Protocol for Three, Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled, Efficacy and Safety Studies of ACP-204 in Adults with Alzheimer's Disease Psychosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,074
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Is male or female and =55 and <85 years of age living in the community or in an institutionalized setting., Able to complete all study visits with a study partner/caregiver, Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable, Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria, Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA), Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD, Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD, MMSE score =6 and =24, Psychotic symptoms for at least 2 months, Lives in a stable place of residence and there are no plans to change living arrangements, Has a designated study partner/caregiver
排除标准
- •Requires treatment with a medication prohibited by the protocol, Is in hospice and receiving end-of-life palliative care, or has become bedridden, Requires skilled nursing care, Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia, Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope, Atrial fibrillation, Symptomatic orthostatic hypotension, Protocol-defined exclusionary clinical laboratory findings, Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
研究者
相似试验
招募中
2 期
ACP-204 in Adults With Alzheimer's Disease PsychosisAlzheimer's Disease PsychosisNCT06159673ACADIA Pharmaceuticals Inc.1,074
招募中
3 期
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's DiseaseJPRN-jRCT2031210210Masaki Takeshi5
进行中（未招募）
1 期
A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)- Crohn´s Disease.- Moderately to severely active Ulcerative Colitis.MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2020-005311-49-PLEli Lilly and Company150
进行中（未招募）
1 期
A rollover study for patients who have participated in a Novartis-sponsored ribociclib (LEE011) study and are continuing to benefit from ribociclib alone or in combination with other agentsEUCTR2016-000293-37-FRovartis Pharma Services AG40
进行中（未招募）
1 期
Rollover study for continued safety and tolerability in subjects treated with spartalizumab alone or in combination with other study treatmentsDifferent types of advanced cancerMedDRA version: 21.0Level: LLTClassification code: 10048683Term: Advanced cancer Class: 10029104MedDRA version: 21.1Level: PTClassification code: 10028997Term: Neoplasm malignant Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104CTIS2023-508841-42-00ovartis Pharma AG119