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NCT04730635 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Merck Sharp & Dohme.

Completed
Registry status
Phase 1
Development phase
44
Enrollment target

NCT04730635: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.

NCT04730635 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04730635, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.

COMPLETED
Registry status
Phase 1
Development phase
44 participants
Enrollment target

Study 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.

Primary Outcome

One Card Learning (OCL) uses a pattern separation paradigm to assess visual memory. The change from baseline of correct responses on the OCL task up to Week 8 is compared in participants receiving donepezil with participants receiving placebo. Change from baseline was the averaged correct response rate at Week 8 minus the correct response rate at baseline.

Interventions

  • DRUG Placebo
  • DRUG Donepezil

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2021-03-23
Est. Completion 2023-02-06
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What the finished NCT04730635 record still lists

NCT04730635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04730635 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04730635 about?

NCT04730635 is a clinical study titled "Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)". 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 Disea...

What is the current status of trial NCT04730635?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2021-03-23. Estimated completion is 2023-02-06.

What interventions are being tested in trial NCT04730635?

The interventions under investigation include: Placebo (DRUG), Donepezil (DRUG).

Who is sponsoring clinical trial NCT04730635?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04730635's enrollment target sits among peer trials

44 1086th of 2000 higher than 901 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04730635, the US trial registry maintained by the National Library of Medicine. NCT04730635 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.