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WF 97116: Phase 3; Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment

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

Objective

Overview

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

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
  • Women ≥18 years old with history of invasive breast cancer
  • Must have completed at least four 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.

Key Exclusion Criteria

A patient will not be eligible for participation in this study if any of the following criteria apply.
  • 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.
  • Pregnant women are excluded from this study. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
  • It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breastfeeding are not eligible for this study.

Phase: III

Learn More

ClinicalTrials.Gov

IRB Protocol Number
WF 97116
Principal Investigator(s)
Dr. Amarinthia Curtis, M.D.

Clinical Trial Categories

  • Symptom Management & Cancer Control
Sponsor(s)
Wake Forest University Health Sciences
How to Participate

Melyssa Foust, RN

864-560-1035

mfoust@gibbscc.org

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