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 in patients with probable Alzheimer's disease (AD).


METHODS
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.


METHODS
University medical centers and community geriatric hospitals in Korea.


METHODS
Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.


METHODS
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.


METHODS
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.
Bae
C Y
CY
Department of Family Medicine and Geriatrics, Pundang CHA Hospital, Pochon CHA Medical University, Kyonggido, Korea.
Cho
C Y
CY
Cho
K
K
Hoon Oh
B
B
Choi
K G
KG
Lee
H S
HS
Jung
S P
SP
Kim
D H
DH
Lee
S
S
Choi
G D
GD
Cho
H
H
Lee
H
H
D000203:Activities of Daily Living; D000368:Aged; D000544:Alzheimer Disease / Q000145:classification / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D000596:Amino Acids / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D018697:Nootropic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D010919:Placebos; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000596:Amino Acids; D018697:Nootropic Agents; D010919:Placebos; C006952:cerebrolysin