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Study · Randomized controlled trial · n = 32 · 2024

5 results

Long-acting exenatide does not prevent cognitive decline in mild cognitive impairment: a proof-of-concept clinical trial.

Dei Cas A, Micheli MM, Aldigeri R, Gardini S, Ferrari-Pellegrini F, Perini M, Messa G, Antonini M, Spigoni V, Cinquegrani G, Vazzana A, Moretti V, Caffarra P, Bonadonna RC

Journal of endocrinological investigation2 Apr 2024Cited by 29 (Europe PMC)

PMID38565814 (opens in a new tab)PMCIDPMC11368991 (opens in a new tab)DOI10.1007/s40618-024-02320-7 (opens in a new tab)PepBankPUB-38565814
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Summary

PurposeAccording to preclinical evidence, GLP-1 receptor may be an actionable target in neurodegenerative disorders, including Alzheimer's disease (AD). Previous clinical trials of GLP-1 receptor agonists were conducted in patients with early AD, yielding mixed results. The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks. The primary endpoint was the change in ADAS-Cog11 cognitive test score at 32 weeks vs baseline. Secondary endpoints herein reported included additional cognitive tests and plasma readouts of GLP-1 receptor engagement. Statistical analysis was conducted by intention to treat.ResultsNo significant between-group effects of exenatide on ADAS-Cog11 score (p = 0.17) were detected. A gender interaction with treatment was observed (p = 0.04), due to worsening of the ADAS-Cog11 score in women randomized to exenatide (p = 0.018), after correction for age, scholar level, dysglycemia, and ADAS-Cog score baseline value. Fasting plasma glucose (p = 0.02) and body weight (p = 0.03) decreased in patients randomized to exenatide.ConclusionIn patients with MCI, a 32-week trial with slow-release exenatide had no beneficial effect on cognitive performance.Trial registration numberNCT03881371, registered on 21 July, 2016.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with mild cognitive impairment, exenatide did not significantly affect ADAS-Cog11 scores compared with no treatment.

    In plain wordsIn patients with mild cognitive impairment, exenatide did not significantly affect cognitive test scores compared with no treatment.

    Peptide
    Exenatide (exendin-4)
    Outcome
    No significant changeADAS-Cog11 score
    Study

    n = 32

    Comparator
    No treatment
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    2 mg once weekly · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    No significant between-group effects of exenatide on ADAS-Cog11 score (p = 0.17) were detected.
    2 context sentences
    Summary · context
    The primary endpoint was the change in ADAS-Cog11 cognitive test score at 32 weeks vs baseline.
    Summary · context
    The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks.
  2. 02HumanRandomized controlled trialOther

    In patients with mild cognitive impairment, sex modified the exenatide treatment effect on ADAS-Cog11 scores.

    In plain wordsIn patients with mild cognitive impairment, the cognitive test effect of exenatide versus no treatment differed by sex.

    Peptide
    Exenatide (exendin-4)
    Outcome
    MixedSex-by-treatment interaction in ADAS-Cog11
    Study

    n = 32

    Comparator
    No treatment
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    2 mg once weekly · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    A gender interaction with treatment was observed (p = 0.04), due to worsening of the ADAS-Cog11 score in women randomized to exenatide (p = 0.018), after correction for age, scholar level, dysglycemia, and ADAS-Cog score baseline value.
    1 context sentence
    Summary · context
    The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In patients with mild cognitive impairment randomized to exenatide, fasting plasma glucose decreased.

    In plain wordsIn patients with mild cognitive impairment who received exenatide, fasting blood sugar decreased.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseFasting plasma glucose
    Study

    n = 17

    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    2 mg once weekly · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    Fasting plasma glucose (p = 0.02) and body weight (p = 0.03) decreased in patients randomized to exenatide.
    1 context sentence
    Summary · context
    The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In patients with mild cognitive impairment randomized to exenatide, body weight decreased.

    In plain wordsIn patients with mild cognitive impairment who received exenatide, body weight decreased.

    Peptide
    Exenatide (exendin-4)
    Outcome
    DecreaseBody weight
    Study

    n = 17

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    2 mg once weekly · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    Fasting plasma glucose (p = 0.02) and body weight (p = 0.03) decreased in patients randomized to exenatide.
    1 context sentence
    Summary · context
    The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In women with mild cognitive impairment randomized to exenatide, adjusted ADAS-Cog11 scores worsened.

    In plain wordsIn women with mild cognitive impairment who received exenatide, adjusted cognitive test scores worsened.

    Peptide
    Exenatide (exendin-4)
    Outcome
    IncreaseADAS-Cog11 score in women
    Study

    n: not reported in source

    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    2 mg once weekly · subcutaneous · 32 weeksAs given in this study (human).

    Source sentences

    Summary
    A gender interaction with treatment was observed (p = 0.04), due to worsening of the ADAS-Cog11 score in women randomized to exenatide (p = 0.018), after correction for age, scholar level, dysglycemia, and ADAS-Cog score baseline value.
    1 context sentence
    Summary · context
    The aim was to assess in a proof-of-concept study whether slow-release exenatide, a long-acting GLP-1 agonist, can benefit the cognitive performance of people with mild cognitive impairment (MCI).MethodsThirty-two (16 females) patients were randomized to either slow-release exenatide (n = 17; 2 mg s.c. once a week) or no treatment (n = 15) for 32 weeks.

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

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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