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Acetylcholinesterase Inhibitor

Donepezil for Alzheimer's Disease

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
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~baseline, up to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage Change From Baseline in Correct Responses on the One Card Learning (OCL) Task to Week 8
Secondary study objectives
Percentage Change From Baseline in the Overall Standard Deviation (sd) in Average OCL Task (Arcsine Square Root Transformed) to Week 8
Percentage of Correct Responses on the OCL Task

Side effects data

From 2009 Phase 4 trial • 220 Patients • NCT00177671
1%
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
4,582,301 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,965 Previous Clinical Trials
5,176,384 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,849 Previous Clinical Trials
8,080,836 Total Patients Enrolled
~10 spots leftby Oct 2025
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