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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1,074
- 试验地点
- 268
- 主要终点
- Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
研究概览
简要总结
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
- Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
- Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
- •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
- •Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association
- •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
- •Able to complete all study visits with a study partner/caregiver
- •Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable
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
- •Treatment with anti-tau therapy or donanemab within 2 months prior to Screening
- •Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
研究组 & 干预措施
ACP-204 60 mg
Administration once daily at approximately the same time of day, with or without food
干预措施: ACP-204 (Drug)
ACP-204 30 mg
Administration once daily at approximately the same time of day, with or without food
干预措施: ACP-204 (Drug)
Placebo
Administration once daily at approximately the same time of day, with or without food
干预措施: Placebo (Drug)
结局指标
主要结局
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
时间窗: From baseline to Week 6
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
次要结局
- Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score(Week 6)
- Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score(Baseline to Week 6)