Early Phase 1 Completed N=13 Supportive Care

Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

Brain and Central Nervous System Tumors · Cognitive/Functional Effects · Long-term Effects Secondary to Cancer Therapy in Children · Neurotoxicity

Source: ClinicalTrials.gov NCT00452868 ↗

Enrolled (actual)

Serious AEs

27.3%

Results posted

Feb 2013

Primary outcomePrimary: Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks — 10 units on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks	10	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00452868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.