CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
Donepezil +1 moredrug
Likely dose
Donepezil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04730635
NCT04730635Phase 1Completed
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A Clinical Study to Evaluate a Cognitive Platform to Support Development of Symptomatic Therapies in Participants at Risk for Alzheimer's Disease

Merck Sharp & Dohme LLC·interventional·Posted Jan 29, 2021·Updated Oct 28, 2024

In Brief

A Phase 1 clinical trial evaluating Donepezil and Placebo for Alzheimer's Disease and Mild Cognitive Impairment. Completed, enrolled 44 participants across 10 sites in 2 countries.

Detailed Summary

The main purpose of this study is to assess the ability of a repeated high-frequency site-based computerized cognitive assessment to evaluate the potential treatment effects of donepezil (MK-0000) compared with placebo among participants with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD). The primary study hypothesis is that the average percentage of correct responses on one card learning (OCL) task will be ≥2 percentage points in participants receiving donepezil compared with participants receiving placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease, Mild Cognitive Impairment
CountriesAustralia, United States
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJan 29, 2021
Enrollment StartMar 23, 2021
Primary CompletionJan 20, 2023
Study CompletionFeb 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago

Interventions

Donepezildrug

Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.

Placebodrug

Dose matched placebo capsule QD, orally for Days 1-56.