Objective: To test the effectiveness of a comprehensive specific care plan in decreasing the rate of functional decline in patients with mild to moderate Alzheimer's disease compared with usual care in memory clinics.
Design: Cluster randomised trial.
Setting: 50 memory clinics in France.
Participants: Patients with Alzheimer's disease (mini-mental state examination score 12-26). 1131 patients were included: 574 from 26 clinics in the intervention group, and 557 from 24 clinics in the usual care (control) group. Memory clinics were the unit of randomisation.
Intervention: The intervention included a comprehensive standardised twice yearly consultation for patients and their caregivers, with standardised guidelines for the management of problems identified during the assessment.
Main outcome measures: The primary outcome measure was change on the Alzheimer's Disease Cooperative Study-activities of daily living scale assessed at 12 and 24 months. Secondary outcome measures were the rate of admission to institutional care and mortality.
Results: At two years the assessment was completed by 58.4% (n=335) of patients in the intervention group and 61.6% (n=343) in the control group. The rate of functional decline at two years did not differ between the groups. The annual rate of change on the Alzheimer's Disease Cooperative Study-activities of daily living was estimated at -5.73 (95% confidence interval -6.89 to -4.57) in the intervention group and -5.96 (-7.05 to -4.86) in the control group (P=0.78).
Conclusion: A comprehensive specific care plan in memory clinics had no additional positive effect on functional decline in patients with mild to moderate Alzheimer's disease. Future research should aim to determine the effects of more direct involvement of general practitioners.
Trial registration: ClinicalTrials.gov NCT00480220.