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Clinical Trials/NCT01496170
NCT01496170
Completed
Phase 1

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)]

Merck Sharp & Dohme LLC0 sites32 target enrollmentDecember 2011
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ConditionsAlzheimer's Disease
InterventionsMK-8931Placebo
DrugsMK-8931Placebo

Overview

Phase
Phase 1
Intervention
MK-8931
Conditions
Alzheimer's Disease
Sponsor
Merck Sharp & Dohme LLC
Enrollment
32
Primary Endpoint
Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40)
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
June 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Treatment A: MK-8931 12 mg

Participants receiving 12 mg MK-8931 for 7 days

Intervention: MK-8931

Treatment B: MK-8931 40 mg

Participants receiving MK-8931 40 mg for 7 days

Intervention: MK-8931

Treatment C: Placebo matching MK-8931 12 mg or 40 mg

Participants receiving placebo matching MK-8931 12 mg or 40 mg for 7 days

Intervention: Placebo

Treatment D: MK-8931 60 mg

Participant receiving MK-8931 60 mg for 7 days

Intervention: MK-8931

Treatment E: Placebo matching MK-8931 60 mg

Participants receiving placebo matching MK-8931 60 mg for 7 days

Intervention: Placebo

Outcomes

Primary Outcomes

Mean population Inhibitory Concentration for 50% Effect (IC50) in cerebral spinal fluid (CSF) ß-amyloid peptide 40 (Aß40)

Time Frame: Hour 0 (predose) to 36 hours post-dose on Day 7

Secondary Outcomes

  • 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)

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