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Study · Randomized controlled trial · n = 53 · 2000

11 results

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

Bae CY, Cho CY, Cho K, Hoon Oh B, Choi KG, Lee HS, Jung SP, Kim DH, Lee S, Choi GD, Cho H, Lee H

Journal of the American Geriatrics Society1 Dec 2000Cited by 31 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with mild to moderate Alzheimer's disease, Cerebrolysin improved ADAS-Cog scores versus placebo (P = .02).

    In plain wordsIn patients with Alzheimer's disease, Cerebrolysin improved cognitive scores more than placebo.

    Outcome
    DecreaseADAS-Cog
    Study

    n = 53

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison
    ADAS-Cog comparison p value
    0.02 p value
    Cerebrolysin versus placebo, ADAS-Cog, after 4 weeks

    Source sentences

    Summary
    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.
    6 context sentences
    Summary · context
    Primary outcome measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Clinical Global Impression of Severity/ Change (CGIS/C).
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with mild to moderate Alzheimer's disease, Cerebrolysin improved CGIS/C scores versus placebo (P = .01).

    In plain wordsIn patients with Alzheimer's disease, Cerebrolysin improved global clinical ratings more than placebo.

    Outcome
    DecreaseCGIS/C
    Study

    n = 53

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison
    CGIS/C comparison p value
    0.01 p value
    Cerebrolysin versus placebo, CGIS/C, after 4 weeks

    Source sentences

    Summary
    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.
    6 context sentences
    Summary · context
    Primary outcome measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Clinical Global Impression of Severity/ Change (CGIS/C).
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with mild to moderate Alzheimer's disease, Cerebrolysin improved MMSE scores versus placebo (P = .04).

    In plain wordsIn patients with Alzheimer's disease, Cerebrolysin improved mental examination scores more than placebo.

    Outcome
    IncreaseMMSE
    Study

    n = 53

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison
    MMSE comparison p value
    0.04 p value
    Cerebrolysin versus placebo, MMSE, after 4 weeks

    Source sentences

    Summary
    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.
    6 context sentences
    Summary · context
    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.
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with Alzheimer's disease, Cerebrolysin did not significantly improve GDS scores versus placebo.

    In plain wordsIn patients with Alzheimer's disease, Cerebrolysin did not significantly improve depression scores compared with placebo.

    Outcome
    No significant changeGeriatric Depression Scale
    Study

    n = 53

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison

    Source sentences

    Summary
    However, there were no significant improvements in the Cerebrolysin group compared with the placebo group on the GDS, ADL, and IADL.
    6 context sentences
    Summary · context
    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.
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In patients with Alzheimer's disease, Cerebrolysin did not significantly improve ADL scores versus placebo.

    In plain wordsIn patients with Alzheimer's disease, Cerebrolysin did not significantly improve daily activities compared with placebo.

    Outcome
    No significant changeActivities of daily living
    Study

    n = 53

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Exercise and physical function · Whole body
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison

    Source sentences

    Summary
    However, there were no significant improvements in the Cerebrolysin group compared with the placebo group on the GDS, ADL, and IADL.
    6 context sentences
    Summary · context
    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.
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In patients with Alzheimer's disease, Cerebrolysin did not significantly improve IADL scores versus placebo.

    In plain wordsIn patients with Alzheimer's disease, Cerebrolysin did not significantly improve instrumental daily activities compared with placebo.

    Outcome
    No significant changeInstrumental activities of daily living
    Study

    n = 53

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Exercise and physical function · Whole body
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison

    Source sentences

    Summary
    However, there were no significant improvements in the Cerebrolysin group compared with the placebo group on the GDS, ADL, and IADL.
    6 context sentences
    Summary · context
    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.
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In patients with Alzheimer's disease, ADAS-Cog improved in 82% with Cerebrolysin versus 31.6% with placebo.

    In plain wordsIn patients with Alzheimer's disease, more Cerebrolysin patients improved on cognitive testing than placebo patients.

    Outcome
    IncreaseADAS-Cog improvement proportion
    Study

    n = 53

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Improved
    82%
    Cerebrolysin ADAS-Cog
    Improved
    31.6%
    placebo ADAS-Cog
    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison

    Source sentences

    Summary
    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.
    6 context sentences
    Summary · context
    Primary outcome measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Clinical Global Impression of Severity/ Change (CGIS/C).
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In patients with Alzheimer's disease, CGIS/C improved in 62% with Cerebrolysin versus 22% with placebo.

    In plain wordsIn patients with Alzheimer's disease, more Cerebrolysin patients improved on global clinical ratings than placebo patients.

    Outcome
    IncreaseCGIS/C improvement proportion
    Study

    n = 53

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Improved
    62%
    Cerebrolysin CGIS/C
    Improved
    22%
    placebo CGIS/C
    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison

    Source sentences

    Summary
    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.
    6 context sentences
    Summary · context
    Primary outcome measures were the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and the Clinical Global Impression of Severity/ Change (CGIS/C).
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In patients with Alzheimer's disease, MMSE improved in 44% with Cerebrolysin versus 17% with placebo.

    In plain wordsIn patients with Alzheimer's disease, more Cerebrolysin patients improved on mental examination scores than placebo patients.

    Outcome
    IncreaseMMSE improvement proportion
    Study

    n = 53

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Improved
    44%
    Cerebrolysin MMSE
    Improved
    17%
    placebo MMSE
    Cerebrolysin group sample size
    34 patients
    Cerebrolysin group, 4-week comparison
    Placebo group sample size
    19 patients
    placebo group, 4-week comparison

    Source sentences

    Summary
    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.
    6 context sentences
    Summary · context
    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.
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
    Summary · context
    The control group (n = 19) received placebo.
    Summary · context
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
  10. 10HumanRandomized controlled trialSafety outcome

    In patients with Alzheimer's disease, neither the Cerebrolysin group nor the placebo group had dropouts.

    In plain wordsIn patients with Alzheimer's disease, no patients discontinued Cerebrolysin or placebo.

    Outcome
    Not applicableDropouts
    Study

    n = 53

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
    3 context sentences
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.
  11. 11HumanRandomized controlled trialOther

    In patients with Alzheimer's disease, compliance was 100% with both Cerebrolysin and placebo.

    In plain wordsIn patients with Alzheimer's disease, all patients complied with Cerebrolysin or placebo treatment.

    Outcome
    Not applicableTreatment compliance
    Study

    n = 53

    Comparator
    Placebo
    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    30 mL once a day from Monday to Friday · IV · 4 weeksAs given in this study (human).

    Measurements

    Compliance
    100%
    Cerebrolysin and placebo

    Source sentences

    Summary
    There were no dropouts in either groups, with 100% compliance to Cerebrolysin and placebo.
    3 context sentences
    Summary · context
    A 4-week randomized, double-blind, placebo-controlled, multicenter clinical trial.
    Summary · context
    Fifty-three men and women at least 50 years of age admitted to hospitals with mild to moderate AD and otherwise in good health.
    Summary · context
    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.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)

WithdrawnPhase 4NCT01822951

Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)

Ever Neuro Pharma GmbHn = 0Completion est. Dec 2016

Alzheimer Disease

Trial pageClinicalTrials.govUpdated 26 Oct 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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