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Type(s) of Cancer
Brain
Study Phase
Phase 3
Study Completion Date
July 2012
NCT00369785Uploaded 12-18-2019
Access via NCI by Request
PDS UID - nci-data-385
Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
Provider Information
Provider Data DescriptionA total of 198 adult brain tumor survivors were randomly assigned to receive donepezil (5 mg for 6 weeks and 10 mg for 18 weeks) or placebo. Neurocognitive tests were assessed at baseline, 12 weeks post randomization, and 24 weeks post randomization. The primary aim of the study was to assess the effect of donepezil on a cognitive composite outcome (consisting of the average of eight standardized tests) at 24 weeks. A secondary aim was to assess the effect of donepezil on the individual tests. There was no significant effect of donepezil on the composite outcome. However, donepezil did significantly improve memory and motor speed/dexterity. This dataset contains all the data used in the publication PMID 25897156.
SponsorWake Forest University Health Sciences
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset198
# of Patients Control0
# of Patients ExperimentalNA
DOIN/A
CDISC StandardNon-SDTM
Study ArmsUndefined
Clinical Trials.gov Information
Brief SummaryRATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors. PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.
ConditionsBrain Tumors
Metastatic Disease
Intervention TypeDrug: donepezil hydrochloride
Drug: Placebo
Drug(s)Drug: donepezil hydrochloride
Drug: Placebo
Total Enrolled198
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionArm I - Donepezil - Experimental
Arm II - Control - Placebo Comparator
Secondary IDU10CA081851
PubMed (PMID)NA
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age RangeMinimum Age: 18 Years
Maximum Age: NA
Files: NCT00369785-D1
Data DictionaryNCT00369785-D1-Data-Dictionary.pdf
DATANCT00369785-D1-Dataset.csv
OTHERREADME.pdf
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