BMJ 1994;308:879-883 (2 April)
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Efficacy of tacrine and lecithin in mild to moderate Alzheimer's disease: double blind trial
N Maltby,
G A Broe,
H Creasey,
A F Jorm,
H Christensen,
W S Brooks
University of Sydney, Department of Geriatric Medicine, Repatriation General Hospital, Concord 2139, Australia National Health and Medical Research Council Social Psychiatry Research Unit, Australian National University, Canberra 0200, Australia Correspondence and requests for reprints to: Professor Broe.
Abstract
Objective : To assess the efficacy of tacrine and lecithin in treating Alzheimer's disease over nine months.
Design : Double blind randomised controlled trial.
Setting : Outpatients clinic of university department of geriatric medicine.
Subjects : 53 subjects (26 women, 27 men) with probable Alzheimer's disease. 41 completed the dose finding phase and were randomised to treatment. 32 (14 tacrine, 18 placebo) completed nine months' treatment.
Interventions : Lecithin and tacrine or lecithin and placebo for 36 weeks.
Main outcome measures : Scores on neuropsychological tests sensitive to deficits in the cholinergic system; mini-mental state score; behaviour change; mood; functional state; and stress in carers. Results - The tacrine and placebo groups were similar except that the tacrine group had a longer duration of disease (mean 5.4 v 2.5 years in placebo group; P=0.003). Only 17 of the 32 patients could tolerate the maximum dose of tacrine (100 mg). No significant difference was found between the groups for any of the tests after nine months' treatment except for the digit backwards test, which is insensitive to cholinergic deficit. Analysis of subjects taking the maximum dose of tacrine and of subjects with mild dementia also found no differences.
Conclusions : Tacrine produces no clinically relevant improvement over 36 weeks at the doses tolerated by these patients.
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Clinical implications
- Clinical implications
- Patients with Alzheimer's disease are thought to have deficits in the cholinergic system
- Patients have been treated with the cholinesterase inhibitor tacrine to enhance cholinergic transmission
- In this study no clinically relevant effect of tacrine was found over nine months of treatment, and nine of the 53 subjects withdrew because of liver toxicity
- Tacrine is not clinically useful for patients with Alzheimer's disease
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