At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 276 enrolled

Drug / intervention

Donepezil 5 mg +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/NCT02822573

NCT02822573Phase 3Completed

Compare CT.gov

A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment

Wake Forest University Health Sciences·interventional·Posted Jul 4, 2016·Updated Sep 13, 2023

In Brief

A Phase 3 clinical trial evaluating Donepezil 5 mg and Placebo for Cognitive Dysfunction and Memory Impairment. Completed, enrolled 276 participants across 278 sites.

Detailed Summary

This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCognitive Dysfunction, Memory Impairment

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished

2017201820192020202120222023202420252026

First PostedJul 2016

Enrollment StartMay 2017

Primary CompletionJul 2022

TodayJul 2026

First PostedJul 4, 2016

Enrollment StartMay 30, 2017

Primary CompletionJul 29, 2022

TodayJul 2, 2026

Enrollment to primary: 5.2 yearsPosted 10.0 years ago

Interventions

Donepezil 5 mgdrug

Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.

Placebodrug

Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.