CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 106 enrolled
Drug / intervention
Comparator: Placebo 5mg (run in) +3 moredrug
Likely dose
Comparator: Placebo 5mg (run in)from 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/NCT00777608
NCT00777608Phase 1Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients

Merck Sharp & Dohme LLC·interventional·Posted Oct 22, 2008·Updated Aug 25, 2015

In Brief

A Phase 1 clinical trial evaluating Comparator: Placebo 5mg (run in), Donepezil 5 - 10 mg, and 2 other interventions for Alzheimer's Disease. Completed, enrolled 106 participants.

Detailed Summary

This study will evaluate the performance of the CogState computerized neuropsychological battery, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) in participants with mild-to-moderate Alzheimer's disease (AD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer's Disease
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2008
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.7 years ago

Interventions

Comparator: Placebo 5mg (run in)drug

Matching placebo to donepezil - 5 mg capsules orally for 14 day run in prior to randomization.

Donepezil 5 - 10 mgdrug

Donepezil 1 capsule (5 mg) orally, once daily for 14 days. Donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).

Comparator: Placebo 5-10 mgdrug

Matching placebo to donepezil, 1 capsule (5 mg) orally, once daily for 14 days. Matching placebo to donepezil 2 capsules (total 10 mg) once daily for 70 days (days 15-84).

Donepezil 10 mgdrug

Donepezil 2 capsules (total 10 mg) orally, once daily for 24 weeks, from day 85 (optional).