NCT04730635

Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)

A Clinical Study to Evaluate a Cognitive Platform to Support Development of Symptomatic Therapies in Participants at Risk for Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Donepezil	Donepezil 5 mg capsules for a total daily dose of up to 10 mg QD, orally, for Days 1-56.
DRUG	Placebo	Dose matched placebo capsule QD, orally for Days 1-56.

Timeline

• Start date: 2021-03-23
• Primary completion: 2023-01-20
• Completion: 2023-02-06
• First posted: 2021-01-29
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

10 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study