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Spots Global Cancer Trial Database for Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

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Trial Identification

Brief Title: Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

Official Title: Adjunctive Donepezil Therapy and Genetic Risk Factors of Cognitive Dysfunction in Brain Tumor Survivors

Study ID: NCT00594633

Study Description

Brief Summary: A significant number of brain tumor patients who received radiation or chemotherapy have thinking problems as a result of their treatment. The purpose of this study is to find out if treatment with Aricept (donepezil) may improve some aspects of thinking abilities in patients with brain tumors who received radiation or chemotherapy. This research will also study whether persons having particular genes for a blood-borne substance called apolipoprotein E (APOE) are more likely to have thinking problems after radiation or chemotherapy treatment for their brain tumors. The findings of this study will help us find out whether Aricept can improve thinking abilities after cancer treatment, and whether some of the thinking difficulties may be in part related to having certain genes.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Memorial Sloan Kettering Cancer Center, New York, New York, United States

Contact Details

Name: Denise Correa, PhD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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