Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation … (NCT00452868) | Clinical Trial Compass
CompletedEarly Phase 1
Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain
United States14 participantsStarted 2006-06
Plain-language 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.
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurocognitive Function as Measured by the Neurocognitive Battery at 24 Weeks