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Memantine Provides Functional Improvement for Advanced Alzheimer's Patients: Presented at ECNP

By Paula Moyer

PRAGUE, CZECH REPUBLIC -- October 14, 2003 -- Patients with advanced Alzheimer's disease experience slower deterioration of their daily living skills when they are treated with memantine (Ebixa), according to findings presented here at the 16^th World Congress of the European College of Neuropsychopharmacology.

"This study shows that there are benefits to treatment with memantine in both cognition and function," said Ursula Windscheif, PhD, researcher, Merz Pharmaceuticals, the developer of the drug. "Treatment was well tolerated; fewer patients dropped out of the treatment group than the placebo group." The lead investigator was Douglas R. Galasko, MD, an associate clinical professor of neurosciences, University of California-San Diego, United States.

Memantine is a moderate-affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist, and has been approved by the Food and Drug Administration in the United States for the treatment of moderate to severe Alzheimer's disease. The investigators wanted to determine whether, in addition to cognition, the treatment had any effect on patients' functional skills.

The investigators enrolled 252 patients with moderately severe to severe Alzheimer's disease in a 28-week, randomised, placebo-controlled study. The patients were at Global Deterioration Scale (GDS) Stages 5 and 6, and had Functional Assessment Staging (FAST) scores of at least 6a, with 1 as a normal score and 7 indicating severe dementia. The patients' Mini Mental Status Examination (MMSE) scores ranged from 3-14.

Patients received either 10 mg of memantine twice daily or placebo. The global endpoint was the Clinician's Interview-Based Impression of Change plus caregiver input (CIBIC-Plus). Two instruments were used to evaluate functional skills, the Alzheimer's Disease Cooperative Activities of Daily Living Inventory modified for severe dementia (ADCS-ADLsev) change in sum scores and FAST scores.

The memantine-treated patients experienced fewer declines than those in the placebo group as measured by CIBIC-Plus changes in score from baseline, with a mean change of 4.38 in the treated group and 4.74 in the placebo group (P=0.0251). The mean difference for the Modified ADCS-ADL change in sum scores from baseline was 2.49 in the memantine group and 5.86 in the placebo group (P=0.0026). The FAST scores in the memantine group had a mean change of 0.13; the mean change in the placebo group was 0.41 (P=0.0200).

The investigators found no clinically important differences in adverse events between groups, with 84% of memantine patients and 87% of placebo patients having any adverse event. The primary adverse events, listed in order of frequency, were: agitation (18% of memantine and 32% of placebo patients); urinary incontinence (11% of patients in each group); diarrhoea (10% of memantine patients and 8% of placebo patients); and urinary-tract infection (6% of memantine patients and 13% of those in the placebo group).

Forest Laboratories, Inc., licensed the drug and will market it in the United States only under the tradename Namenda.


[Study title: Functional Improvement From Treatment With The NMDA Antagonist Memantine: Results Of A 28-Week, Randomized, Placebo-Controlled Study In Advanced Alzheimer's Disease. Abstract P4-005]

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