A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 457
- 试验地点
- 133
- 主要终点
- Change From Baseline on the CDR-SB
研究概览
简要总结
This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Additional blinded personnel will include study site personnel who will evaluate participant status, contract research organization (CRO) personnel who will review case report forms (CRFs), and other sponsor agents (with the exception of the interactive voice or web-based response system [IxRS] vendor).
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Dose 1 Semorinemab
干预措施: Semorinemab (Drug)
Dose 1 Semorinemab
干预措施: [18F]GTP1 (Drug)
Dose 2 Semorinemab
干预措施: Semorinemab (Drug)
Dose 2 Semorinemab
干预措施: [18F]GTP1 (Drug)
Dose 3 Semorinemab
干预措施: Semorinemab (Drug)
Dose 3 Semorinemab
干预措施: [18F]GTP1 (Drug)
Placebo
干预措施: [18F]GTP1 (Drug)
结局指标
主要结局
Change From Baseline on the CDR-SB
时间窗: Baseline and 73 Weeks
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
Other Abnormal MRI Findings
时间窗: Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89
Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.
Percentage of Participants With Adverse Events
时间窗: Up to the data cutoff date 15 January 2021 (up to approximately 39 months)
Percentage of participants with at least one adverse event
Change From Baseline on the C-SSRS
时间窗: Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)
Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is "Wish to be dead", SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.
次要结局
- Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)(Baseline and 73 weeks)
- Serum Concentrations of Semorinemab at Specified Timepoints(Up to 109 weeks)
- Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score(Baseline and 73 weeks)
- Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire(Baseline and 73 weeks)
- Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory(Baseline and 73 weeks)
- Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline(Up to 109 weeks)