Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors
A significant proportion of brain tumor patients treated with radiation or chemotherapy who
are in disease remission experience cognitive sequelae from their treatment. Cognitive
dysfunction can be of sufficient severity to interfere with their ability to function at
premorbid professional and social levels. There are, however, no approved pharmacological
interventions for improving cognitive functions in cancer patients who display
treatment-related cognitive deficits. Donepezil, an acetylcholinesterase inhibitor, has been
shown to provide cognitive and functional benefits in patients with Alzheimer's disease,
vascular dementia, and in patients with other neurological diseases without known
cholinergic deficiency. The proposed pilot study will examine the efficacy of donepezil in
improving cognitive functions in adult brain tumor patients treated with radiation and/or
chemotherapy who have mild to moderate cognitive difficulties. Neuropsychological measures
of executive, psychomotor speed, attention, and memory abilities will be administered prior
to, during and following donepezil therapy. The proposed study will also test the hypothesis
that the apolipoprotein E (APOE) e-4 allele correlates with the development of cognitive
impairment after radiation or chemotherapy treatments. The proposed investigation is
unprecedented and may provide preliminary information about (1) a pharmacological therapy
that could improve cognitive functions in this population, and (2) a genetic risk factor
that may increase vulnerability to radiation or chemotherapy-induced cognitive decline.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary goal of this study is to assess the efficacy of donepezil in improving executive abilities and psychomotor speed in adult brain tumor patients who have undergone cranial irradiation and/or chemotherapy.
conclusion of study
No
Denise Correa, PhD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
04-122
NCT00594633
October 2004
October 2013
Name | Location |
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Memorial Sloan Kettering Cancer Center | New York, New York 10021 |