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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

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

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

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 • NCT00177671

Suicide Attempt

Myocardial infarcation with congestive heart failure

stroke

100%

80%

60%

40%

20%

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

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