J&J JNJ announces 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.
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