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New Long-Term Study Suggests Lower Mortality in Alzheimer's Patients Treated with Galantamine Versus Placebo
Date:12/5/2012

to month 24, was significantly worse in the placebo group than in the galantamine group (P=0.002). The DAD is a validated measure of activities of daily living.

About the Study

The randomized, double-blind, placebo-controlled clinical study was designed to evaluate the safety and efficacy of long-term (two-year) treatment with galantamine in patients with mild to moderately severe Alzheimer's disease.

The primary safety endpoint was the rate of mortality or death over two years. The secondary safety endpoint was the incidence of treatment emergent adverse events, including serious adverse events, over two years.

Approximately 49 percent of the placebo group and 54 percent of the galantamine group reported at least one Treatment Emergent Adverse Event (TEAE). Approximately 12 percent of patients reported serious adverse events in both groups. Patients who were treated with galantamine reported numerically more TEAEs, most notably gastrointestinal disorders (nausea, vomiting). The incidence and types of serious AEs were similar in both groups, except for mortality, which was significantly higher in the group of patients that received placebo.

The primary efficacy endpoint was the change from baseline in the MMSE score at month 24. Secondary efficacy endpoints included cognitive change from baseline to month 6 as measured by the MMSE, and change in function from baseline to month 24 as measured by the DAD.

The trial enrolled 2,051 people (1,023 to the placebo group, 1,028 to the galantamine group) and was conducted at 127 sites in 13 countries. Patients in the study were between the ages of 45 and 92; their mean age was approximately 73 years. The majority of patients was female (65 percent).

The galantamine group initially received 8 mg of drug daily, and the dose was increased to 16 to 24 mg daily during the first 12 weeks of the study. Thereafter, patients were maintained on 16 to 24 mg of galantamine daily.<
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SOURCE Janssen Research & Development, LLC
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