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A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy

Primary Objective Determine whether the addition of memantine to WBRT preserves cognitive function, specifically memory as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R delayed recall), over that of placebo and WBRT in patients with brain metastases at 24 weeks from the start of drug treatment. Secondary Objectives Determine whether the addition of memantine preserves cognitive function, specifically memory as measured by the HVLT-R-delayed recall at 8 weeks, 16 weeks and 12 months from the start of drug treatment. Determine whether the addition of memantine increases time to neurocognitive failure as measured by cognitive decline on a battery of tests: the HVLT-R for free recall, delayed recall, and delayed recognition; the Controlled Word Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status Examination (MMSE). (3/28/08) Evaluate the potential benefit of memantine in change and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br). Determine whether the addition of memantine increases progression-free survival. Determine whether the addition of memantine increases overall survival. Compare adverse events between the treatment arms according to the CTCAE v3.0 criteria. Collect serum, plasma, buffy coat cells, urine, and CSF for future translational research analyses

Primary Objective Determine whether the addition of memantine to WBRT preserves cognitive function, specifically memory as measured by the Hopkins Verbal Learning Test-Revised for delayed recall (HVLT-R delayed recall), over that of placebo and WBRT in patients with brain metastases at 24 weeks from the start of drug treatment. Secondary Objectives Determine whether the addition of memantine preserves cognitive function, specifically memory as measured by the HVLT-R-delayed recall at 8 weeks, 16 weeks and 12 months from the start of drug treatment. Determine whether the addition of memantine increases time to neurocognitive failure as measured by cognitive decline on a battery of tests: the HVLT-R for free recall, delayed recall, and delayed recognition; the Controlled Word Association Test (COWAT); the Trail Making Test Parts A and B (TMT); the Medical Outcomes Scale-Cognitive Functioning Subscale (MOS); and the Mini-Mental Status Examination (MMSE). (3/28/08) Evaluate the potential benefit of memantine in change and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br). Determine whether the addition of memantine increases progression-free survival. Determine whether the addition of memantine increases overall survival. Compare adverse events between the treatment arms according to the CTCAE v3.0 criteria. Collect serum, plasma, buffy coat cells, urine, and CSF for future translational research analyses