OBJECTIVE: To evaluate the efficacy and safety of galantamine in the
treatment of Alzheimer's disease.
DESIGN: Randomised, double blind,
parallel group, placebo controlled trial.
SETTING: 86 outpatient clinics in
Europe and Canada.
PARTICIPANTS: 653 patients with mild
to moderate Alzheimer's disease.
INTERVENTION: Patients randomly
assigned to galantamine had their daily dose escalated over three to four weeks
to maintenance doses of 24 or 32 mg.
MAIN OUTCOME MEASURES: Scores on the
11 item cognitive subscale of the Alzheimer's disease assessment scale, the
clinician's interview based impression of change plus caregiver input, and the
disability assessment for dementia scale. The effect of apolipoprotein E4
genotype on reponse to treatment was also assessed.
RESULTS: At six months, patients who
received galantamine had a significantly better outcome on the 11 item cognitive
subscale of the Alzheimer's disease assessment scale than patients in the
placebo group (mean treatment effect 2.9 points for lower dose and 3.1 for
higher dose, intention to treat analysis, P<0.001 for both doses).
Galantamine was more effective than placebo on the clinician's interview based
impression of change plus caregiver input (P<0.05 for both doses v placebo).
At six months, patients in the higher dose galantamine group had significantly
better scores on the disability assessment for dementia scale than patients in
the placebo group (mean treatment effect 3.4 points, P<0.05). Apolipoprotein E genotype had no effect on the efficacy of galantamine. 80%
(525) of patients completed the study.
CONCLUSION: Galantamine is
effective and well tolerated in Alzheimer's disease. As galantamine slowed
the decline of functional ability as well as cognition, its effects are likely
to be clinically relevant..