Finding studies
Finding studies
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Lead
Wake Forest University Health Sciences
With
OBJECTIVES: Primary * Determine the effect of donepezil or EGb761 on neurocognitive function in patients who underwent radiotherapy for a primary brain tumor or brain metastases at least 6 months before study registration. Secondary * Determine the toxicity of these drugs in these patients. * Determine the quality of life of patients treated with these drugs. * Quantify the extent of radiation-induced white matter disease and temporal lobe atrophy in patients treated with these drugs. OUTLINE: This is an open-label, multicenter study. * Group 1 (closed to accrual 10/09/03): Patients receive oral donepezil once daily for 24 weeks. * Group 2: Patients receive oral EGb761 three times daily for 24 weeks. In both groups (group 1 closed to accrual 10/09/03), treatment continues in the absence of unacceptable toxicity. In both groups (group 1 closed to accrual 10/09/03), quality of life and neurocognitive assessment is performed at baseline and at weeks 6 (group 1 only), 12, 24, and 30. Patients are followed at 6 weeks. PROJECTED ACCRUAL: A total of 70 patients (35 per treatment group) will be accrued for this study within 9.5 months. (Group 1 closed to accrual 10/09/03)
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
