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New Data Highlights Positive Results of Namenda (Memantine HCl) Once-Daily Extended-Release Formulation
Date:7/30/2008

cutive Vice President and Chief Medical Officer at Forest added, "With this novel formulation, the efficacy and tolerability of Namenda is delivered in a more convenient, once-daily dose."

About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatients already taking a cholinesterase inhibitor was conducted in multiple centers in the United States, Argentina, Chile, and Mexico. Patients in the 24-week study were randomly assigned to receive either 28 mg/day of memantine once-daily extended-release or placebo. The primary endpoints evaluated were change from baseline on the Severe Impairment Battery (SIB) and the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) rating at week 24. The study showed statistically significantly higher cognitive abilities, as measured by the SIB, and clinical global status, as measured by the CIBIC-Plus, in patients treated with memantine 28 mg once-daily extended-release compared to placebo (p=0.001 for SIB and p=0.008 for CIBIC-Plus, both using pre-defined last observation carried forward analyses). The CIBIC-Plus is a global measure of a patient's overall status evaluating cognition, behavior, and activities of daily living.

Results for a secondary endpoint and additional assessment variables reinforced the positive findings seen with the primary endpoints. Assessments were conducted to evaluate change in behavior from baseline using the Neuropsychiatric Inventory (NPI) at 24 weeks and change in verbal fluency from baseline using the Verbal (Semantic) Fluency Test at 24 weeks. Memantine provided significant benefits over placebo (p=0.005 for NPI and p=0.004 for verbal fluency). Measurement of daily living activities using the 19-item AD Cooperative Study-Activities of Daily Living scale (ADCS-ADL) demonstrated maintenance of function during the study period, but this was not significantly different from placebo (p=0.18).

The study a
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