BMJ 2000;321:1445 ( 9 December )

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Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multicentre randomised controlled trial

Gordon K Wilcock, professor in care of the elderly, a Sean Lilienfeld, director, b Els Gaens, statistician, b on behalf of the Galantamine International-1 Study Group.

a Department of Care of the Elderly, Frenchay Hospital, University of Bristol, Bristol BS16 1LE, b Central Nervous System Clinical Research, Janssen Research Foundation, Beerse, Belgium

Correspondence to: G K Wilcock Gordon.Wilcock{at}bris.ac.uk

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.


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Rapid Responses:

Read all Rapid Responses

Correction: Patients in galantamine for Alzheimer's trial were mainly non-smokers
Jonathan Foulds
bmj.com, 12 Dec 2000 [Full text]
Re: Correction: Patients in galantamine for Alzheimer's trial were mainly non-smokers
Gordon Wilcock
bmj.com, 13 Dec 2000 [Full text]
Showdown
Ron Law
bmj.com, 13 Dec 2000 [Full text]
Re: Re: Correction: Patients in galantamine for Alzheimer's trial were mainly non-smokers
Frank M Berger
bmj.com, 21 Dec 2000 [Full text]
Re: Re: Re: Correction: Patients in galantamine for Alzheimer's trial were mainly non-smokers
Gordon Wilcock
bmj.com, 22 Dec 2000 [Full text]
Date and dose
Dominique Somme, et al.
bmj.com, 29 Dec 2000 [Full text]
Re: Date and dose
Gordon Wilcock
bmj.com, 3 Jan 2001 [Full text]
Response to galantamine may be greater in patients homozygous for the ApoE4 allele
Cornelius Katona, et al.
bmj.com, 17 Jan 2001 [Full text]
Improvements in functional ability with galantamine in Alzheimer’s have not yet been established
Richard Gray
bmj.com, 17 Jan 2001 [Full text]
Apo E genotype and response to galantamine
Gordon Wilcock
bmj.com, 27 Jan 2001 [Full text]
Re: Improvements in functional ability with galantamine in Alzheimer’s have not yet been established
Sean Lilienfeld
bmj.com, 14 Feb 2001 [Full text]
Re:Improvements in functional ability with galantamine in Alzheimer’s have not yet been established
David Wilkinson
bmj.com, 20 Feb 2001 [Full text]
Response to Prof Gray's letter
Gordon Wilcock
bmj.com, 1 Mar 2001 [Full text]
Galantamine seems also to be modestly effective in Treating Children with Autistic Disorder
Helmut Niederhofer
bmj.com, 18 Oct 2002 [Full text]
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