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A Double-Blind, Placebo-Controlled, Multicenter Study of Cerebrolysin for Alzheimer's Disease

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Author(s)
Chul-Young BaeChoo-Yon ChoKyunghee ChoByoung Hoon OhKyoung Gyu ChoiHong Soo LeeSeung PilJungDae Hyun KimSangdo LeeGyu-Dong ChoiHangsuk ChoHotaek Lee
Keimyung Author(s)
Yi, Sang DoKim, Dae Hyun
Department
Dept. of Neurology (신경과학)
Dept. of Family Medicine (가정의학)
Journal Title
Journal of the American Geriatrics Society
Issued Date
2000
Volume
48
Issue
12
Keyword
cerebrolysinAlzheimer's diseaseclinical trial
Abstract
OBJECTIVE: To assess the efficacy and safety of Cerebrolys in over 4 weeks in patients with probable Alzheimer's disease (AD).
DESIGN: A 4-week randomized, double-blind, placebocontrolled,multicenter clinical trial. An unequal (Cerebrolysin:
placebo = 2:l) 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 (CGWC). 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 = .Ol), 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 placebotreated
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.
Keimyung Author(s)(Kor)
이상도
김대현
Publisher
School of Medicine
Citation
Chul-Young Bae et al. (2000). A Double-Blind, Placebo-Controlled, Multicenter Study of Cerebrolysin for Alzheimer’s Disease. Journal of the American Geriatrics Society, 48(12), 1566–1571. doi: 10.1111/j.1532-5415.2000.tb03865.x
Type
Article
ISSN
0002-8614
Source
https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1532-5415.2000.tb03865.x
DOI
10.1111/j.1532-5415.2000.tb03865.x
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/33725
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Family Medicine (가정의학)
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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