Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group.
OBJECTIVE
To evaluate the efficacy and safety of galantamine in the treatment of Alzheimer's disease.


METHODS
Randomised, double blind, parallel group, placebo controlled trial.


METHODS
86 outpatient clinics in Europe and Canada.


METHODS
653 patients with mild to moderate Alzheimer's disease.


METHODS
Patients randomly assigned to galantamine had their daily dose escalated over three to four weeks to maintenance doses of 24 or 32 mg.


METHODS
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.


CONCLUSIONS
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.
Wilcock
G K
GK
Department of Care of the Elderly, Frenchay Hospital, University of Bristol, Bristol BS16 1LE. Gordon.Wilcock@bris.ac.uk
Lilienfeld
S
S
Gaens
E
E
D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005702:Galantamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D018697:Nootropic Agents; D005702:Galantamine