一项评估ML-007C-MA治疗阿尔茨海默氏病精神病的功效和安全性的研究
一项随机，双盲的，安慰剂对照的研究，以评估ML-007C-MA在治疗与阿尔茨海默氏病有关的幻觉和妄想治疗的功效和安全性
ML-007C-MA-221 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ML-007C-MA in male and female participants aged 55 to 90 years with hallucinations and delusions associated with Alzheimer's Disease Psychosis (ADP).
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo for the treatment of hallucinations and delusions associated with ADP as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Clinical Trials Contact Center
- 电话号码：+1 650 839 4380
- 邮箱：ML-007C-MA-ADP@maplightrx.com
学习地点
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Córdoba、Córdoba Province、阿根廷、X5009BIN
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
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Willing and able to provide written informed consent, or, if deemed lacking in the capacity to provide informed consent, the following requirements for consent must be met:
- The participant's LAR must provide written informed consent AND
- The participant will provide informed assent.
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Meets clinical criteria for Possible AD or Probable AD.
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Presence of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months before Screening.
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Has resided at the same home, residential assisted living, or nursing home facility for a minimum of 6 weeks before Screening.
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Has a designated care partner who is in contact with the participant frequently enough to accurately report on the participant's symptoms and adherence to study drug.
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Has a NPI-C H+D score of ≥ 6 AND meet at least 1 of the following criteria:
- Moderate to severe delusions, defined as NPI-C Delusions domain score of ≥ 2 on at least 2 of the 8 items OR
- Moderate to severe hallucinations, defined as NPI-C Hallucinations domain score of ≥ 2 on at least 2 of the 7 items.
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Has a (CGI)-S hallucinations and delusions domain-specific score ≥4
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Has an Mini-mental State Examination (MMSE) score of 6 to 26, inclusive.
Key Exclusion Criteria:
- Under the care of hospice, bed-bound, or receiving end-of-life palliative care.
- Psychotic symptoms that are primarily attributable to substance abuse or a medical, neurological or psychiatric condition other than Alzheimer's disease.
- Evidence of a CNS disorder other than Alzheimer's disease that is the primary cause of, or a significant contributor to the participant's dementia.
- Moderate or severe major depressive episode within 3 months of Screening, according to DSM-5 criteria.
- Has an elevated risk of suicidal behavior
- Has had an amyloid PET brain scan or CSF Alzheimer's disease biomarker test in the past 3 years with results inconsistent with a diagnosis of AD.
- Evidence of a clinically significant and/or unstable medical condition that, in the opinion of the investigator or medical monitor, could substantially impair cognition, compromise participant safety, interfere with the participant's ability to comply with study procedures or substantially impair the evaluation of efficacy or safety assessments.
- Gastric retention, urinary retention or narrow-angle (angle-closure) glaucoma
- Meets or has met DSM-5 criteria for alcohol or substance use disorder within the past 12 months (excluding caffeine and nicotine).
- Has previously participated in any clinical study with ML-007 or ML-007C-MA.
- Has developed an allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients.
- Received or may have received an investigational drug, biological product or device within 90 days before Baseline (or 6 months for investigational Alzheimer's disease-modifying therapies).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Placebo Tablets |
|
实验性的：ML-007C-MA
|
ML-007C-MA dosed as 105/1.5 mg BID, or 210/3 mg BID |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C H+D) score
大体时间：Baseline and End of Treatment (7 weeks)
|
NPI-C H+D scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes. |
Baseline and End of Treatment (7 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) hallucinations and delusions domain-specific score
大体时间：Baseline and End of Treatment (7 weeks)
|
The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the participant's hallucinations and delusions using the investigator's judgment and past experience with participants who have Alzheimer's disease psychosis. Higher scores on this scale indicate worse outcomes. |
Baseline and End of Treatment (7 weeks)
|
|
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory - Clinician Agitation and Aggression (NPI-C A+A) score in participants who have a CGI-S agitation/aggression domain-specific score of ≥4 at Baseline
大体时间：Baseline and End of Treatment (7 weeks)
|
NPI-C A+A scale includes 2 domains from the NPI-C scale, namely, agitation and aggression. These 2 domains include the following number of items to be rated by the clinician: Agitation, 13 items (maximum score = 39), and Aggression, 8 items (maximum score = 24). The maximum score for the NPI-C A+A scale is 63. Higher scores on this scale indicate more severe symptoms of agitation and aggression. |
Baseline and End of Treatment (7 weeks)
|
合作者和调查者
调查人员
- 研究主任：MapLight Therapeutics、MapLight Therapeutics
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- ML-007C-MA-221
- 2024-519820-26-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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