A Randomized, Double-blind, Placebo-Controlled, Parallel, 24-Week, Phase 2 Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Subjects With Mild to Moderate Probable Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 33
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
研究概览
简要总结
This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.
Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Probable Alzheimer's disease
- •Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
- •Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
- •Female subjects are ≥1 year post-menopausal or are surgically sterile
- •Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
- •Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
- •General health status acceptable for participation in a 24 week clinical trial be administered
排除标准
- •Participation in another therapeutic clinical trial within 30 days before Baseline
- •Prior participation in an amyloid vaccination clinical study
- •Inability to swallow capsules
- •Likely inability to complete 24 week study
- •Inability to be ≥75% compliant with single-blind placebo run-in medication
- •Inability to adequately perform cognitive tests
- •History of significant cardiovascular disease
- •Major depression
- •Psychosis
- •History of stroke within 18 months of screening
- •Head trauma
- •Inability to perform any screening or baseline evaluations
研究组 & 干预措施
EVP-6124 0.3 mg
one 0.3 mg capsule every day for 183 days
干预措施: EVP-6124 (Drug)
EVP-6124 1 mg
one 1 mg capsule every day for 183 days
干预措施: EVP-6124 (Drug)
EVP-6124 2 mg
one 2 mg capsule every day for 183 days
干预措施: EVP-6124 (Drug)
Placebo
Placebo every day for 183 days
干预措施: Placebo (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-cog-13)
时间窗: Day -7, Baseline, 4, 12, 18, 23 Weeks
次要结局
- Alzheimer's Disease Assessment Scale-Cognitive subscale-11(4, 12, 18, 23 Weeks)
- Controlled Oral Word Association Test(Day -7, Baseline, 4, 12, 18, 23 Weeks)
- Category Fluency Test(Day -7, Baseline, 4, 12, 18, 23 Weeks)
- Clinical Dementia Rating Scale Sum of Boxes(Day -7, Baseline, 4, 12, 18, 23 Weeks)
- Alzheimer's Disease Cooperative Study-Activities of Daily Living(Baseline, 4, 12, 18, 23 Weeks)
- Neuropsychiatric Inventory(Baseline, 12, 23 Weeks)
- Mini-Mental State Exam(Day -7, Baseline, 4, 12, 18, 23 Weeks)