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A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease.

Abstract

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.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Family Medicine and Geriatrics, Pundang CHA Hospital, Pochon CHA Medical University, Kyonggido, Korea.

    , , , , , , , , , ,

    Source

    MeSH

    Activities of Daily Living
    Aged
    Alzheimer Disease
    Amino Acids
    Double-Blind Method
    Female
    Geriatric Assessment
    Humans
    Male
    Mental Status Schedule
    Middle Aged
    Nootropic Agents
    Placebos
    Severity of Illness Index
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    11129744

    Citation

    Bae, C Y., et al. "A Double-blind, Placebo-controlled, Multicenter Study of Cerebrolysin for Alzheimer's Disease." Journal of the American Geriatrics Society, vol. 48, no. 12, 2000, pp. 1566-71.
    Bae CY, Cho CY, Cho K, et al. A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease. J Am Geriatr Soc. 2000;48(12):1566-71.
    Bae, C. Y., Cho, C. Y., Cho, K., Hoon Oh, B., Choi, K. G., Lee, H. S., ... Lee, H. (2000). A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease. Journal of the American Geriatrics Society, 48(12), pp. 1566-71.
    Bae CY, et al. A Double-blind, Placebo-controlled, Multicenter Study of Cerebrolysin for Alzheimer's Disease. J Am Geriatr Soc. 2000;48(12):1566-71. PubMed PMID: 11129744.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A double-blind, placebo-controlled, multicenter study of Cerebrolysin for Alzheimer's disease. AU - Bae,C Y, AU - Cho,C Y, AU - Cho,K, AU - Hoon Oh,B, AU - Choi,K G, AU - Lee,H S, AU - Jung,S P, AU - Kim,D H, AU - Lee,S, AU - Choi,G D, AU - Cho,H, AU - Lee,H, PY - 2000/12/29/pubmed PY - 2001/2/28/medline PY - 2000/12/29/entrez SP - 1566 EP - 71 JF - Journal of the American Geriatrics Society JO - J Am Geriatr Soc VL - 48 IS - 12 N2 - 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. SN - 0002-8614 UR - https://www.unboundmedicine.com/medline/citation/11129744/A_double_blind_placebo_controlled_multicenter_study_of_Cerebrolysin_for_Alzheimer's_disease_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0002-8614&date=2000&volume=48&issue=12&spage=1566 DB - PRIME DP - Unbound Medicine ER -