NCT00594633|CompletedPhase 1
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Sponsor study identifier
interventional
25
1 country
1
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
January 7, 2008
Actual (reported)January 16, 2008
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)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
This study will also assess the efficacy of donepezil in improving other cognitive domains such as attention, memory, and general cognition in this population.
conclusion of study
The study will also explore the possibility that the possession of the apolipoprotein E (APOE) є-4 allele is associated with the development of cognitive difficulties following cranial radiation and/or chemotherapy treatments.
conclusion of study
donepezil and questionaires
Patients will undergo a brief cognitive evaluation prior to (baseline/Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 1), Cognitive Re-Evaluation (about 12 weeks after Time 2) ,Cognitive Re-Evaluation (about 6 months after discontinuation of Donepezil). Then pt will be tx with donepezil, an acetylcholinesterase inhibitor. They will undergo a four-week dose titration (i.e., 5mg QD during weeks 1-4) to reach a final dose of 10mg QD of oral donepezil there after for a maximum of 24 weeks.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Denise Correa, PhD
Memorial Sloan Kettering Cancer Center
25 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
January 14, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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