Advertisement
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
In the study, patients treated with once-daily extended-release Namendaexperienced significant improvements in cognitive performance and globalclinical status compared to those receiving placebo. Patients treated withonce-daily extended-release Namenda also experienced significant improvementsin verbal fluency and behavioral symptoms as compared to placebo. The resultsbuild on preliminary findings announced by Forest in February.
Advertisement
"While there is no cure or existing treatment to prevent Alzheimer'sdisease, there are currently-available FDA-approved treatments, such ascombination therapy with memantine and a cholinesterase inhibitor, which canalleviate symptoms by providing cognitive, functional, and behavioralbenefits," said George Grossberg, MD, Director of Geriatric Psychiatry atSaint Louis University School of Medicine, and the lead investigator whopresented the data. "These findings reinforce the safety, tolerability andefficacy of memantine in a newly-developed once-a-day formulation."
Marco Taglietti, MD, Executive Vice President and Chief Medical Officer atForest added, "With this novel formulation, the efficacy and tolerability ofNamenda is delivered in a more convenient, once-daily dose."
About the Study
A randomized, double-blind, placebo-controlled trial of 677 outpatientsalready taking a cholinesterase inhibitor was conducted in multiple centers inthe United States, Argentina, Chile, and Mexico. Patients in the 24-week studywere randomly assigned to receive either 28 mg/day of memantine once-dailyextended-release or placebo. The primary endpoints evaluated were change frombaseline on the Severe Impairment Battery (SIB) and the Clinician'sInterview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) ratingat week 24. The study showed statistically significantly higher cognitiveabilities, as measured by the SIB, and clinical global status, as measured bythe CIBIC-Plus, in patients treated with memantine 28 mg once-dailyextended-release compared to placebo (p=0.001 for SIB and p=0.008 forCIBIC-Plus, both using pre-defined last observation carried forward analyses).The CIBIC-Plus is a global measure of a patient's overall status evaluatingcognition, behavior, and activities of daily living.
Results for a secondary endpoint and additional assessment variablesreinforced the positive findings seen with the primary endpoints. Assessmentswere conducted to evaluate change in behavior from baseline using theNeuropsychiatric Inventory (NPI) at 24 weeks and change in verbal fluency frombaseline using the Verbal (Semantic) Fluency Test at 24 weeks. Memantineprovided significant benefits over placebo (p=0.005 for NPI and p=0.004 forverbal fluency). Measurement of daily living activities using the 19-item ADCooperative Study-Activities of Daily Living scale (ADCS-ADL) demonstratedmaintenance of function during the study period, but this was notsignificantly different from placebo (p=0.18).
The study also demonstrated that once-daily extended-release memantine waswell tolerated. The treatment-emergent AEs (TEAEs) profile was similarbetween the groups; no TEAEs were experienced by greater than or equal to 5%of memantine patients, and at an incidence at least twice that
