NCT01496170已完成1 期
A Study to Assess the Safety, Tolerability, and Pharmacodynamics of MK-8931/SCH 900931 in Patients With Alzheimer's Disease [Phase 1b; Protocol No. 010-00 (Also Known as P07820)]
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40)
研究概览
简要总结
This study will assess the safety and pharmacodynamics of three different doses of MK-8931, a ß-secretase inhibitor, in participants with mild to moderate Alzheimer's Disease (AD).
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A: MK-8931 12 mg
Experimental
Participants receiving 12 mg MK-8931 for 7 days
干预措施: MK-8931 (Drug)
Treatment B: MK-8931 40 mg
Experimental
Participants receiving MK-8931 40 mg for 7 days
干预措施: MK-8931 (Drug)
Treatment C: Placebo matching MK-8931 12 mg or 40 mg
Placebo Comparator
Participants receiving placebo matching MK-8931 12 mg or 40 mg for 7 days
干预措施: Placebo (Drug)
Treatment D: MK-8931 60 mg
Experimental
Participant receiving MK-8931 60 mg for 7 days
干预措施: MK-8931 (Drug)
Treatment E: Placebo matching MK-8931 60 mg
Placebo Comparator
Participants receiving placebo matching MK-8931 60 mg for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40)
时间窗: Hour 0 (predose) to 36 hours post-dose on Day 7
次要结局
- Change in CSF Aß40 concentration determined by time-weighted average from 0 to 24 hours (TWA0-24)(Baseline, and assessment over 24 hours post Day 7 dose)
- Change in CSF soluble amyloid precursor protein ß (sAPPß ) concentration determined by TWA0-24(Baseline, and assessment over 24 hours post Day 7 dose)
研究者
相似试验
已完成
1 期
MK-8189 Multiple Dose Study in Healthy Volunteers and Schizophrenia Participants (MK-8189-003)SchizophreniaNCT02181803Merck Sharp & Dohme LLC55
已完成
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK0683 in Patients With Advanced Cancer (0683-008)Cancer, AdvancedNCT00750178Merck Sharp & Dohme LLC30
终止
1 期
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)Hepatitis C, ChronicNCT01554189Merck Sharp & Dohme LLC37
已完成
1 期
Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-8666 in Participants With Type 2 Diabetes Mellitus (MK-8666-003)Type 2 Diabetes MellitusNCT01971554Merck Sharp & Dohme LLC63
已完成
1 期
A Single and Multiple-Dose Study of MK-8521 in Healthy and Obese Males (MK-8521-002)Type 2 Diabetes MellitusNCT02055547Merck Sharp & Dohme LLC61