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A Double‐Blind, Placebo‐Controlled, Multicenter Study of Cerebrolysin for Alzheimer's Disease
Author(s) -
Bae ChulYoung,
Cho ChooYon,
Cho Kyunghee,
Oh Byoung Hoon,
Choi Kyoung Gyu,
Lee Hong Soo,
Jung Seung Pil,
Kim Dae Hyun,
Lee Sangdo,
Choi GyuDong,
Cho Hangsuk,
Lee Hotaek
Publication year - 2000
Publication title -
journal of the american geriatrics society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.992
H-Index - 232
eISSN - 1532-5415
pISSN - 0002-8614
DOI - 10.1111/j.1532-5415.2000.tb03865.x
Subject(s) - cerebrolysin , medicine , placebo , activities of daily living , physical therapy , clinical trial , randomization , geriatric depression scale , alzheimer's disease , randomized controlled trial , disease , psychiatry , cognition , depressive symptoms , pathology , alternative medicine
OBJECTIVE: To assess the efficacy and safety of Cerebrolysin over 4 weeks in 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 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 admitted to hospitals with mild to moderate AD and otherwise in good health. INTERVENTION: The treatment group (n = 34) received Cerebrolysin (30 mL Cerebrolysin 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 Assessment Scale‐Cognitive subscale (ADAS‐Cog) and the Clinical Global Impression of Severity/Change (CGIS/C). Secondary outcome measures included Mini‐Mental State Examination (MMSE), Geriatric Depression Scale (GDS), Katz Index of Activities of Daily Living (ADL), and Lawton Instrumental Activities of Daily Living (IADL) Scale. RESULTS: After 4 weeks of treatment, Cerebrolysin‐treated patients demonstrated significant improvements in the ADAS‐Cog ( P = .02), CGIS/C ( P = .01), and MMSE (P = .04) compared with placebo‐treated patients. Among Cerebrolysin‐treated patients, 82%, 62%, and 44% were rated improved on ADAS‐Cog, CGIS/C, and MMSE, respectively, 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. CONCLUSIONS: This study indicates that Cerebrolysin is a safe drug that improves the cognitive deficits and global function in patients with mild to moderate AD. Long‐term efficacy and safety of Cerebrolysin in Alzheimer's patients should be evaluated in the future.