A Phase 2-3, 6-12 Month, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimer's Disease Who Are APOE4(-)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
研究概览
简要总结
The study will evaluate the safety & efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).
详细描述
Two primary outcome measures will be assessed in APOE4(-) patients:
- differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months
- differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 & placebo groups' scores for these same instruments at 3 months.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females between age of 55 -85 years
- •MMSE scores between 16-26
- •Probable mild to moderate AD
排除标准
- •Presence of other CNS disorders as alternative causes of dementia
- •Type 1 or Type 2 diabetes
- •Significant renal/hepatic disease
研究组 & 干预措施
AC-1204
干预措施: caprylic triglyceride (Drug)
Placebo
干预措施: long-chain triglyceride (Drug)
结局指标
主要结局
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
时间窗: 6 months
change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients
次要结局
- Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)(6 months)