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Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil - WF 97116

2016-07-05 22:38:21 | BioPortfolio

Summary

This study is to compare the safety and effects of donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer.

Description

A randomized, placebo controlled, double-blind, parallel group Phase 3 design will be used to assess the effect of 24 weeks of donepezil on cognitive function (memory) in breast cancer survivors who report having cognitive dysfunction and demonstrate memory impairment 1-5 year post chemotherapy. Patients who meet the eligibility criteria will be stratified by age (<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo with equal probability.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cognitive Dysfunction

Intervention

Donepezil 5 mg, Placebo

Location

Wake Forest School of Medicine
Winston Salem
North Carolina
United States
27157

Status

Not yet recruiting

Source

Wake Forest NCORP Research Base

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-07-05T22:38:21-0400

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