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Study · Randomized controlled trial · 2022

5 results

Modulation of Amyloid-β and Tau in Alzheimer's Disease Plasma Neuronal-Derived Extracellular Vesicles by Cerebrolysin® and Donepezil.

Alvarez XA, Winston CN, Barlow JW, Sarsoza FM, Alvarez I, Aleixandre M, Linares C, García-Fantini M, Kastberger B, Winter S, Rissman RA

Journal of Alzheimer's disease : JAD1 Jan 2022Cited by 19 (Europe PMC)

Summary

BackgroundPlasma neuronal-derived extracellular vesicles (NDEV) contain proteins of pathological, diagnostic, and therapeutic relevance.ObjectiveWe investigated the associations of six plasma NDEV markers with Alzheimer's disease (AD) severity, cognition and functioning, and changes in these biomarkers after Cerebrolysin®, donepezil, and a combination therapy in AD.MethodsPlasma NDEV levels of Aβ42, total tau, P-T181-tau, P-S393-tau, neurogranin, and REST were determined in: 1) 116 mild to advanced AD patients and in 20 control subjects; 2) 110 AD patients treated with Cerebrolysin®, donepezil, or combination therapy in a randomized clinical trial (RCT). Samples for NDEV determinations were obtained at baseline in the NDEV study and at baseline and study endpoint in the RCT. Cognition and functioning were assessed at the same time points.ResultsNDEV levels of Aβ42, total tau, P-T181-tau, and P-S393-tau were higher and those of neurogranin and REST were lower in mild-to-moderate AD than in controls (p < 0.05 to p < 0.001). NDEV total tau, neurogranin, and REST increased with AD severity (p < 0.05 to p < 0.001). NDEV Aβ42 and P-T181-tau correlated negatively with serum BDNF (p < 0.05), and total-tau levels were associated to plasma TNF-α (p < 0.01) and cognitive impairment (p < 0.05). Combination therapy reduced NDEV Aβ42 with respect to monotherapies (p < 0.05); and NDEV total tau, P-T181-tau, and P-S396-tau were decreased in Cerebrolysin-treated patients compared to those on donepezil monotherapy (p < 0.05).ConclusionThe present results demonstrate the utility of NDEV determinations of pathologic and synaptic proteins as effective AD biomarkers, as markers of AD severity, and as potential tools for monitoring the effects of anti-AD drugs.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialMechanism

    In AD patients, Cerebrolysin plus donepezil reduced NDEV Aβ42 compared with donepezil monotherapy.

    In plain wordsIn AD patients, Cerebrolysin plus donepezil reduced NDEV Aβ42 compared with donepezil alone.

    Outcome
    DecreaseCombination NDEV Aβ42 versus donepezil
    Study

    n: not reported in source

    Comparator
    Donepezil monotherapy
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    p value for NDEV Aβ42 reduction
    < 0.05
    Cerebrolysin plus donepezil versus donepezil monotherapy

    Source sentences

    Summary
    Combination therapy reduced NDEV Aβ42 with respect to monotherapies (p < 0.05)
    1 context sentence
    Summary · context
    2) 110 AD patients treated with Cerebrolysin®, donepezil, or combination therapy in a randomized clinical trial (RCT).
  2. 02HumanRandomized controlled trialMechanism

    In AD patients, Cerebrolysin reduced NDEV total tau compared with donepezil monotherapy.

    In plain wordsIn AD patients, Cerebrolysin reduced NDEV total tau compared with donepezil alone.

    Outcome
    DecreaseNDEV total tau
    Study

    n: not reported in source

    Comparator
    Donepezil monotherapy
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    p value for NDEV total tau
    < 0.05
    Cerebrolysin versus donepezil monotherapy

    Source sentences

    Summary
    and NDEV total tau, P-T181-tau, and P-S396-tau were decreased in Cerebrolysin-treated patients compared to those on donepezil monotherapy (p < 0.05).
    1 context sentence
    Summary · context
    2) 110 AD patients treated with Cerebrolysin®, donepezil, or combination therapy in a randomized clinical trial (RCT).
  3. 03HumanRandomized controlled trialMechanism

    In AD patients, Cerebrolysin reduced NDEV P-T181-tau compared with donepezil monotherapy.

    In plain wordsIn AD patients, Cerebrolysin reduced NDEV P-T181-tau compared with donepezil alone.

    Outcome
    DecreaseNDEV P-T181-tau
    Study

    n: not reported in source

    Comparator
    Donepezil monotherapy
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    p value for NDEV P-T181-tau
    < 0.05
    Cerebrolysin versus donepezil monotherapy

    Source sentences

    Summary
    and NDEV total tau, P-T181-tau, and P-S396-tau were decreased in Cerebrolysin-treated patients compared to those on donepezil monotherapy (p < 0.05).
    1 context sentence
    Summary · context
    2) 110 AD patients treated with Cerebrolysin®, donepezil, or combination therapy in a randomized clinical trial (RCT).
  4. 04HumanRandomized controlled trialMechanism

    In AD patients, Cerebrolysin reduced NDEV P-S396-tau compared with donepezil monotherapy.

    In plain wordsIn AD patients, Cerebrolysin reduced NDEV P-S396-tau compared with donepezil alone.

    Outcome
    DecreaseNDEV P-S396-tau
    Study

    n: not reported in source

    Comparator
    Donepezil monotherapy
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition
    Studied dose
    Dose not stated

    Measurements

    p value for NDEV P-S396-tau
    < 0.05
    Cerebrolysin versus donepezil monotherapy

    Source sentences

    Summary
    and NDEV total tau, P-T181-tau, and P-S396-tau were decreased in Cerebrolysin-treated patients compared to those on donepezil monotherapy (p < 0.05).
    1 context sentence
    Summary · context
    2) 110 AD patients treated with Cerebrolysin®, donepezil, or combination therapy in a randomized clinical trial (RCT).

Studies that did not test the peptide alone1

In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Cerebrolysin.

  1. 05HumanNot a test of Cerebrolysin aloneRandomized controlled trialMechanism

    In AD patients, Cerebrolysin plus donepezil reduced NDEV Aβ42 compared with Cerebrolysin monotherapy.

    In plain wordsIn AD patients, Cerebrolysin plus donepezil reduced NDEV Aβ42 compared with Cerebrolysin alone.

    Outcome
    DecreaseCombination NDEV Aβ42 versus Cerebrolysin
    Study

    n: not reported in source

    Comparator
    Cerebrolysin monotherapy
    Outcome group
    Receptor activity and mechanism · Nervous system and cognition

    Measurements

    p value for Combination NDEV Aβ42 versus Cerebrolysin
    < 0.05
    Cerebrolysin plus donepezil versus Cerebrolysin monotherapy

    Source sentences

    Summary
    Combination therapy reduced NDEV Aβ42 with respect to monotherapies (p < 0.05)
    1 context sentence
    Summary · context
    2) 110 AD patients treated with Cerebrolysin®, donepezil, or combination therapy in a randomized clinical trial (RCT).

    In this study, Cerebrolysin was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Cerebrolysin.

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

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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