Korean Study

OBJECTIVE : To assess the efficacy and safety of Cerebrolysin over 4 weeks in patients with probable Alzheimer's disease. DESIGN : A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial. An unequal (Cerebrolysin:placebo=2:1) randomization was used to assign more patients to the treatment group. SETTINGS : University medical centers and Community geriatric hospitals in Korea. PARTICIPANTS : Fifty-three men and women at least 50 years of age with mild to moderate Alzheimer's disease and otherwise in good health. INTERVENTION : The treatment group(n=34) received Cerebrolysin(30ml Cerebrolysin in 100ml physiologic saline i.v.) 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 Assessment Scale-Cognitive subscale (ADAS-Cog), and Clinical Global Impression of Severity/Change (CGIS/C). Secondary outcome measures included Mini-Mental State Examination(MMSE), Geriatric Depression Scale(GDS), Katz Index of Activity of Daily Living(ADL), and Law-ton Instrumental Activity of Daily Living (IADL) scale. RESULTS : After four weeks of treatment, Cerebrolysin-treated patients demonstrated significant improvements in the ADAS-Cog(P=0.02), CGIS/C(P=0.01), and MMSE(P=0.04) compared with placebo-treated patients. 82%, 62%, and 44% of Cerebroiysin-treated patients on ADAS-Cog, CGIS/C, and MMSE, respectively, were rated improved compared with 31.6%, 22%, and 17% of placebo-treated patients, respectively. However, there were no significant improvements in the Cerebrolysin group compared with the placebo group on the GDS, ADL, 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. CONCLUSION : This study indicates that Cerebrolysin is a safe drug that improves the cognitive deficits and global function in patients with mild to moderate Alzheimer's disease. Long-term efficacy and safety of Cerebrolysin in Alzheimer's patients should be evaluated in the future.