Abstract | OBJECTIVE: DESIGN: Randomised, double blind, parallel group, placebo controlled trial. SETTING: 86 outpatient clinics in Europe and Canada. PARTICIPANTS: 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:
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Authors | G K Wilcock, S Lilienfeld, E Gaens |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 321
Issue 7274
Pg. 1445-9
(Dec 09 2000)
ISSN: 0959-8138 [Print] England |
PMID | 11110737
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Nootropic Agents
- Galantamine
|
Topics |
- Aged
- Alzheimer Disease
(drug therapy)
- Double-Blind Method
- Europe
- Female
- Galantamine
(adverse effects, therapeutic use)
- Humans
- Male
- Nootropic Agents
(adverse effects, therapeutic use)
- Treatment Outcome
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