A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 421
- 试验地点
- 129
- 主要终点
- Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
研究概览
简要总结
This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.
详细描述
Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants originally randomized to receive placebo in the double-blind feeder study AZES and switched to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants originally randomized to receive LY3314814 in the double-blind feeder study.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.
排除标准
- •Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.
研究组 & 干预措施
AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg
Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
干预措施: Lanabecestat (Drug)
AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg
Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
干预措施: Lanabecestat (Drug)
AZES Placebo/AZFD Lanabecestat 20 mg
Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.
干预措施: Lanabecestat (Drug)
AZES Placebo/AZFD Lanabecestat 50 mg
Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.
干预措施: Lanabecestat (Drug)
结局指标
主要结局
Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
时间窗: AZES Baseline through AZFD Week 26
ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.
次要结局
- Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)(AZES Baseline through AZFD Week 26)
- Change From Baseline on the Functional Activities Questionnaire (FAQ) Score(AZES Baseline through AZFD Week 26)
- Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score(AZES Baseline through AZFD Week 26)
- Change From Baseline on the Mini-Mental Status Examination (MMSE)(AZES Baseline through AZFD Week 26)
- Change From Baseline Analysis on the ADAS-Cog13(AZES Baseline through AZFD Week 52)