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Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
Overall Recruitment Status: Active, enrollment completed
Official Title
A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors with Cognitive Impairment (WF 97116)
Region Sponsors
Wake Forest University Health Sciences
Acronym KP IRB No.
(Remember) STUDY00000748
Study Type Phase
Clinical Trial Phase III
Study Population Description
(Adult, Older Adult) Female with Cognitive Dysfunction, Memory Impairment, breast cancer
This study is to compare the safety and effects of donepezil (Aricept) or if it decreases memory loss after receiving chemotherapy for breast cancer.
Detailed Description
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).
Gender Age Limit
Female 18 - 75 years
Inclusion Criteria
  • Women >=18 years old with history of invasive breast cancer
  • Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (Ongoing herceptin or other chronic HER 2 directed therapies are allowed)
  • Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
  • Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted (patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet) if dose is stable over previous 12 weeks
  • Self-reported cognitive problem plus a measured memory deficit (score <7 on single trial of Eligibility Pre-screen HVLT-R Form C)
  • Prior treatment with > 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy
  • ECOG performance status 0-2
  • Ability to understand and the willingness to sign a written informed consent document
  • Must be able to speak English
Exclusion Criteria
  • Evidence or suspected recurrent or metastatic disease. Prior brain irradiation is not allowed
  • Patients may not currently be taking Ketoconazole or Quinidine History of dementia, Alzheimer's disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)
  • Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to registration
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia
  • Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia
  • Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse
  • Untreated current severe depression. Currently treated depression is permitted if treatment is stable
  • It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study
  • Please contact study team for additional exclusion criteria

Keywords and/or Specific Medical Conditions
  • breast cancer
  • memory impairment
  • Cholinergic Agents
  • Mental Disorders
  • Cholinesterase Inhibitors
  • Molecular Mechanisms of Pharmacological Action
  • Cognition Disorders
  • Neurocognitive Disorders
  • cognitive dysfunction
  • Neurotransmitter Agents
  • Cognitive Dysfunction
  • Nootropic Agents
  • Donepezil
  • Physiological Effects of Drugs
  • Enzyme Inhibitors
  • WF-97116
  • IRB00041707
  • Oncology (Adult)
KP Clinical Facility
  • Central Interstate Medical Office
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Sandeep Mashru, MD
Contact Information:
- Rhonda Stephenson, RN
-Central Interstate Medical Office

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