Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT00452868
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT00452868
Study Brief:
Protocol Section:
NCT00452868