EFFICACY OF TACRINE AND LECITHIN IN MILD-TO-MODERATE ALZHEIMERS-DISEASE - DOUBLE-BLIND TRIAL

Objective-To assess the efficacy of tacrine and lecithin in treating A lzheimer's disease over nine months. Design-Double blind randomised co ntrolled Setting-Outpatients clinic of university department of geriat ric medicine. Subjects-53 subjects (26 women, 27 men) with probable Al zheimer's disease. 41 completed the dose finding phase and were random ised 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 test s sensitive to deficits in the cholinergic system; mini-mental state s core; behaviour change; mood; functional state; and stress in carers. Results-The tacrine and placebo groups were similar except that the ta crine 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 cholinerg ic deficit. Analysis of subjects taking the maximum dose of tacrine an d of subjects with mild dementia also found no differences. Conclusion s-Tacrine produces no clinically relevant improvement over 36 weeks at the doses tolerated by these patients.