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Acetylcholinesterase Inhibitor
Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)
Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to week 8
Summary
This trial is testing whether donepezil can improve memory and thinking skills in people with early stages of memory problems. The medication works by boosting brain chemicals important for these functions. Donepezil has been approved in numerous countries for the treatment of Alzheimer's disease.
Eligible Conditions
- Alzheimer's Disease
- Mild Cognitive Impairment
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Averaged Correct Response Rate on the One Card Learning Task to Week 8
Secondary study objectives
Change From Baseline in Averaged Correct Response Rate on the OCL Task to Week 8 in Participants Receiving Donepezil
Change From Baseline in Standard Deviation for Averaged Correct Response Rate on the OCL Task (Arcsine Square Root Transformed) to Week 8
Side effects data
From 2009 Phase 4 trial • 220 Patients • NCT001776711%
Suicide Attempt
1%
Myocardial infarcation with congestive heart failure
1%
stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DonepezilExperimental Treatment1 Intervention
Participants receive donepezil in doses up to 10 mg once daily (QD), orally in a scheduled titration for Days 1-56. The total treatment duration is 56 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants receive placebo QD, orally for Days 1-56. The total treatment duration is 56 Days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Donepezil
2011
Completed Phase 4
~2070
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,444 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,759 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,900 Previous Clinical Trials
8,090,390 Total Patients Enrolled