A double-blind, placebo-controlled, multicenter study of cerebrolysin for Alzheimer's disease

OBJECTIVE: To assess the efficacy and safety of Cerebrolysin over 4 weeks i n patients with probable Alzheimer's disease (AD). DESIGN: A 4-week randomized, double-blind, placebo controlled, multicenter clinical trial. An unequal (Cerebrolysin:placebo = 2:1) randomization was u sed to assign more patients to the treatment group. SETTINGS: University medical centers and community geriatric hospitals in K orea. PARTICIPANTS: Fifty-three men and women at least 50 years of age admitted t o hospitals with mild to moderate AD and otherwise in good health. INTERVENTION: The treatment group (n = 34) received Cerebrolysin (30 mL Cer ebrolysin in 100 mL physiologic saline IV) once a day from Monday to Friday for 4 weeks. The control group (n = 19) received placebo. MEASUREMENTS: Primary outcome measures were the Alzheimer's Disease Assessm ent Scale-Cognitive subscale (ADAS-Cog) and the Clinical Global Impression of Severity/Change (CGIS/C). Secondary outcome measures included Mini-Menta l State Examination (MMSE), Geriatric Depression Scale (GDS), Katz Index of Activities of Daily Living (ADL), and Lawton Instrumental Activities of Da ily Living (IADL) Scale. RESULTS: After 4 weeks of treatment, Cerebrolysin-treated patients demonstr ated significant improvements in the ADAS-Cog (P = .02), CGIS/C (P = .01), and MMSE (P = .04) compared with placebo-treated patients. Among Cerebrolys in-treated patients, 82%, 62%, and 44% were rated improved on ADAS-Cog, CGI S/C, and MMSE, respectively, compared with 31.6%, 22%, and 17% of placebo-t reated patients, respectively. However, there were no significant improveme nts in the Cerebrolysin group compared with the placebo group on the GDS, A DL, and IADL. There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo. Only one patient reported a febrile sensation , which was transient and mild in severity. CONCLUSIONS: This study indicates that Cerebrolysin is a safe drug that imp roves the cognitive deficits and global function in patients with mild to m oderate AD. Long-term efficacy and safety of Cerebrolysin in Alzheimer's pa tients should be evaluated in the future.