Clinical trial · Interventional
Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor
Donepezil and EGb761 in Improving Neurocognitive Function in Patients Who Have Previously Undergone Radiation Therapy for Primary Brain Tumor or Brain Metastases
- 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 and EGb761 may be effective in improving neurocognitive function (such as thinking, attention, concentration, and memory) and may improve quality of life in patients who have undergone radiation therapy to the brain. PURPOSE: This phase II trial is studying how well donepezil or EGb761 works in improving neurocognitive function in patients who have undergone radiation therapy for primary brain tumor or brain metastases.
Conditions
Conditions (2)
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 | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cognitive assessment | Procedure | — | UNRESOLVED |
| donepezil hydrochloride | Drug | — | UNRESOLVED |
| EGb761 | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of primary brain tumor or brain metastases, meeting 1 of the following criteria: * No radiographic evidence of disease * Stable disease, defined as no tumor progression within the past 3 months * Previously treated with 1 course of localized or whole brain radiotherapy of at least 3,000 cGy at least 6 months before study registration PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 30 weeks Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No concurrent chemotherapy Endocrine therapy * Concurrent steroid therapy allowed if on stable or decreasing dose Radiotherapy * See Disease Characteristics * No concurrent cranial radiotherapy Surgery * No concurrent surgery Other * More than 3 months since prior donepezil or EGb761 * No concurrent donepezil (group 2 only) * No concurrent EGb761 (group 1 only) (closed to accrual 10/09/03) * No concurrent anticoagulants (e.g., aspirin, dipyridamole, heparin, warfarin, or enoxaparin) (group 2 only) * No concurrent monoamine oxidase inhibitors (e.g., phenelzine or tranylcypromine) * No other concurrent therapy
References
Publications (1)
- RESULTShaw EG, Rosdhal R, D'Agostino RB Jr, Lovato J, Naughton MJ, Robbins ME, Rapp SR. Phase II study of donepezil in irradiated brain tumor patients: effect on cognitive function, mood, and quality of life. J Clin Oncol. 2006 Mar 20;24(9):1415-20. doi: 10.1200/JCO.2005.03.3001. PMID 16549835