HOLLYWOOD, Fla., Dec. 5, 2012 /PRNewswire/ -- New study findings presented today showed a significantly lower mortality rate in patients who were treated with galantamine, a prescription medicine for mild to moderately severe Alzheimer's disease, versus those who received placebo. Patients treated with galantamine also had significantly lesser decline in cognitive impairment after two years, compared to patients in the placebo group, according to investigators presenting the data at the American College of Neuropsychopharmacology 51 st Annual Meeting in Hollywood, Fla. Janssen Research & Development, LLC, sponsored the study.
At the study's final interim mortality analysis, an independent Data Safety Monitoring Board recommended early termination of the study due to an imbalance of deaths between the treatment group and the placebo group. Subsequent unblinding of the data indicated that mortality was statistically significantly lower in patients treated with galantamine, compared to patients who received placebo [3.1 percent versus 4.9 percent respectively; ( P=0.021)]. In the final analysis, there was a total of 89 deaths; 33 (3.2 percent) in the galantamine group and 56 (5.5 percent) in the placebo group ( P=0.011).
The treatment group also had significantly lesser cognitive decline measured by the change from baseline in the Mini Mental Status Evaluation (MMSE) at month 24 of the study, compared to the group treated with placebo. The mean MMSE scores deteriorated from a baseline of 19 to 16.9 and 17.5 for the placebo and galantamine groups, respectively ( P<0.001). The MMSE is a validated measure of cognition.
Additionally, there was a significantly greater decline from baseline in MMSE at month 6 in the placebo group compared with the galantamine group ( P<0.001). The change in activities of daily living, as measured by the Disability Assessment in Dementia (DAD) scores from baseline 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.