Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Alzheon Inc.
- 入组人数
- 163
- 试验地点
- 81
- 主要终点
- Primary cognitive efficacy endpoint 2
研究概览
简要总结
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
详细描述
This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, were eligible for enrollment. Subjects will be treated for 104 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
- •Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.
排除标准
- •Significant worsening of medical conditions that may preclude completion of this study.
- •Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
- •Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
- •Subject taking any prohibited medications per protocol.
研究组 & 干预措施
Experimental: ALZ-801
ALZ-801 265 mg BID tablet orally. Subjects will take one 265 mg tablet of ALZ-801 in the evening during the first 4 weeks of the study; thereafter, they will take one 265 mg tablet BID.
干预措施: Experimental: ALZ-801 (Drug)
结局指标
主要结局
Primary cognitive efficacy endpoint 2
时间窗: Week 104
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of this study to Week 52 and Week 104.
Primary cognitive efficacy endpoint 1
时间窗: Week 104
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs)
时间窗: Week 104
Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
Primary imaging biomarker endpoint 1
时间窗: Week 104
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of the Phase 3 core study (ALZ-801-AD301) to Week 52 and Week 104 of this long-term extension study (ALZ-801-AD351).
Primary imaging biomarker endpoint 2
时间窗: Week 104
Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of this study to Week 52 and Week 104.
次要结局
- Secondary cognitive efficacy endpoint 2(Week 104)
- Secondary functional efficacy endpoint(Week 104)
- Secondary global assessment efficacy endpoint(Week 104)
- Secondary cognitive efficacy endpoint 1(Week 104)
- Secondary cognitive efficacy endpoint 3(Week 104)
- Secondary imaging biomarker endpoint(Week 104)
- Secondary fluid biomarker endpoint(Week 104)