A RANDOMIZED, CONTROLLED TRIAL OF LINOPIRDINE IN THE TREATMENT OF ALZHEIMERS-DISEASE

Objectives: We tested the efficacy and safety of linopirdine, a novel phenylindolinone, in the treatment of Alzheimer's disease. Methods: A multicentre, randomized, double-blind, parallel group, placebo-control led trial of linopirdine (30 mg three times per day or placebo). Patie nts (n = 382, 55% male, 98% Caucasian, age range 51-95 years) with mil d or moderate Alzheimer's disease, of whom 375 received at least one t reatment dose were analysed. There were no important differences betwe en the groups at baseline. Results: No difference was seen in Clinical Global Impression scores between patients receiving placebo and those receiving linopirdine (n = 189). Small differences in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores were se en throughout the study favouring linopirdine; at 6 months the ADAS-Co g scores were 20.2 (linopirdine) and 22.1 (placebo) p = 0.01. Conclusi ons: This trial did not detect clinically meaningful differences in pa tients receiving linopirdine for 6 months, despite evidence of a small degree of improved cognitive function. Further studies may benefit fr om more sensitive tests of treatment effects in Alzheimer's disease.