EFFICACY AND SAFETY OF BMY-21,502 IN ALZHEIMER-DISEASE

OBJECTIVE: To assess the efficacy and safety of BMY 21,502, a nootropi c agent, in patients with mild-to-moderate Alzheimer disease. DESIGN A ND PARTICIPANTS: Sixty-nine patients with Alzheimer disease (28 men, 4 1 women, mean age 72 y, range 54-92, mean Mini-Mental State Examinatio n [MMSE] score 23.5) were randomized to receive either BMY 21,502 (n = 34) or placebo (n = 35) for 12 weeks of double-blind treatment follow ed by a 4-week placebo washout period. SETTING: Outpatient research fa cility. MEASUREMENTS: Primary efficacy assessments were the Alzheimer' s Disease Assessment Scale (ADAS) and the Clinical Global Impressions Scale. The computerized Neurological Test Battery and MMSE were perfor med as secondary efficacy measurements. RESULTS: Although overall effe cts were not statistically significant (p > 0.05), patients taking BMY 21,502 showed a mean change in ADAS cognitive score of -1.5 points at week 12, compared with -0.5 in patients who received placebo. Patient s with moderate dementia (MMSE less than or equal to 20) showed a grea ter change at week 12 with BMY 21,502 (-2.7 points) compared with plac ebo (+0.3 points), but the difference was not statistically significan t. Although BMY 21,502 was well tolerated in general, patients treated with BMY 21,502 experienced higher rates of abnormal liver enzyme con centrations and nausea than did those in the placebo group, There was also a higher rate of discontinuations in the BMY 21,502 group, with 1 2 of 34 (35%) patients in the BMY 21,502 group discontinuing, compared with 3 of 35 (9%) in the placebo group (p < 0.05). CONCLUSIONS: In th is pilot study. BMY 21,502 was not found to be significantly superior to placebo during the treatment period. The compound was generally wel l tolerated, although 8 of 34 (24%) patients discontinued active drug treatment. Further evaluations of BMY 21,502 in a laerger study popuat on may be warranted.