A Study of the Safety, Tolerability, and Pharmacodynamics of MK-8931 in Participants With Alzheimer's Disease (MK-8931-010 AM1 [P07820 AM1])
- Registration Number
- NCT01496170
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment B: MK-8931 40 mg MK-8931 Participants receiving MK-8931 40 mg for 7 days Treatment D: MK-8931 60 mg MK-8931 Participant receiving MK-8931 60 mg for 7 days Treatment A: MK-8931 12 mg MK-8931 Participants receiving 12 mg MK-8931 for 7 days Treatment C: Placebo matching MK-8931 12 mg or 40 mg Placebo Participants receiving placebo matching MK-8931 12 mg or 40 mg for 7 days Treatment E: Placebo matching MK-8931 60 mg Placebo Participants receiving placebo matching MK-8931 60 mg for 7 days
- Primary Outcome Measures
Name Time Method Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40) Hour 0 (predose) to 36 hours post-dose on Day 7
- Secondary Outcome Measures
Name Time Method 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