Cy. Bae et al., A double-blind, placebo-controlled, multicenter study of cerebrolysin for Alzheimer's disease, J AM GER SO, 48(12), 2000, pp. 1566-1571
Citations number
33
Categorie Soggetti
Public Health & Health Care Science","General & Internal Medicine
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.