Kaiser Permanente-Walnut Creek(0.7 mi away)Contact
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invasive breast cancer
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.
Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or
placebo followed by a 12 week wash-out period. 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. A total of 276 patients will be enrolled (138 per arm). We expect an
accrual rate of 7-10 participants per month based on our prior feasibility study. We expect
the study to be complete within 40 months.
Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching
placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil
or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will
begin a 12 week wash-out period.
Time points for performing study assessments. Participants will be administered the cognitive
battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a
single vial of blood will be drawn at baseline for APOE genotyping and subsequent bioassays
(pending supplemental funding).
disturbance of memory,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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