CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 14 enrolled
Drug / intervention
Donepezildrug
Likely dose
Donepezil 5 milligrams a day for 6 weeksAI-extracted
Key inclusion· 6
  • ✓Prior diagnosis of primary brain tumor
  • ✓Underwent fractionated radiotherapy (≥23.4 Gy) with or without surgery or chemotherapy for the brain tumor at least 1 year ago
  • ✓Karnofsky or Lansky performance status 70-100%
  • ✓Baseline IQ ≥70 on Peabody Picture Vocabulary Test-3
Key exclusion· 9
  • ✕No type 2 neurofibromatosis
  • ✕Stereotactic radiosurgery as sole treatment
  • ✕Evidence of disease progression by MRI
  • ✕Pregnant or nursing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00452868
NCT00452868Early Ph 1Completed
CompareCT.gov

A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation

Wake Forest University Health Sciences·interventional·Posted Mar 28, 2007·Updated Sep 7, 2018

In Brief

A Early Phase 1 clinical trial evaluating Donepezil for Brain and Central Nervous System Tumors and 5 related conditions. Completed, enrolled 14 participants across 2 sites.

Detailed Summary

RATIONALE: Donepezil may decrease the side effects caused by radiation therapy to the brain. PURPOSE: This clinical trial is studying how well donepezil works in treating young patients with primary brain tumors previously treated with radiation therapy to the brain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Early Ph 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2007
Enrollment StartJun 1, 2006
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 19.3 years ago

Interventions

Donepezildrug

Donepezil 5 milligrams a day for 6 weeks