Clinical trial · Interventional
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
A Pilot Study of Donepezil Hydrochloride in Pediatric Brain Tumor Survivors After Cranial Irradiation
NCT00452868CI-TRIAL-00034758completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Children | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donepezil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Donepozil
- description
- Donepezil 5 milligrams a day for 6 weeks
- interventionNames
- Drug: Donepezil
Primary outcomes (1)
- measure
- Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks
- timeFrame
- 24 weeks
- description
- Delis-Kaplan Executive Function System Tower Total Scaled Score, range is 1-19 with the higher score being a better outcome.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Prior diagnosis of primary brain tumor * No type 2 neurofibromatosis * 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% * Fertile patients willing to use effective contraception * Baseline IQ ≥ 70 on Peabody Picture Vocabulary Test-3 * Stable weight within the past 6 months with no concern of weight loss * Vision aids and hearing aids must be used for all neuropsychologic/neurocognitive tests, If indicated * Able to speak English * More than 6 weeks since prior donepezil hydrochloride, EGb761, methylphenidate hydrochloride, other stimulants, or any other cognitive function-enhancing drug Exclusion Criteria: * Stereotactic radiosurgery as sole treatment * Evidence of disease progression by MRI * Pregnant or nursing * Attention-deficit/hyperactivity disorder before cancer diagnosis * Uncontrolled seizures or uncontrolled endocrinopathies * Uncontrolled comorbidities * Steroid dose greater than physiologic replacement (18-30 mg/m² hydrocortisone or equivalent) * Use of concurrent anticholinergic drugs
References
Publications (0)
Data not yet available
No reference posted for this study.