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Study · Randomized controlled trial · n = 144 · 2013

3 results

A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment.

Morimoto BH, Schmechel D, Hirman J, Blackwell A, Keith J, Gold M

Dementia and geriatric cognitive disorders13 Apr 2013Cited by 93 (Europe PMC)

PMID23594991 (opens in a new tab)DOI10.1159/000348347 (opens in a new tab)PepBankPUB-23594991
Publisher pagePubMedAsk about this study
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In amnestic mild cognitive impairment, AL-108 was generally safe and well tolerated.

    In plain wordsIn people with amnestic mild cognitive impairment, AL-108 was generally safe and well tolerated.

    Peptide
    Davunetide
    Outcome
    Not applicableGeneral safety and tolerability
    Study

    n = 144

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    AL-108 was generally safe and well tolerated.
    2 context sentences
    Summary · context
    AL-108-211 was a placebo-controlled, ascending-dose study that explored the safety, tolerability and efficacy of 12 weeks of treatment with AL-108 in subjects with amnestic mild cognitive impairment.
    Summary · context
    A total of 144 subjects were randomized in a 2:1 drug:placebo ratio.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In amnestic mild cognitive impairment, AL-108 did not significantly differ from placebo on the composite cognitive memory score.

    In plain wordsIn people with amnestic mild cognitive impairment, AL-108 and placebo did not significantly differ on the combined memory score.

    Peptide
    Davunetide
    Outcome
    No significant changeComposite cognitive memory score
    Study

    n = 144

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Analyses of efficacy data failed to detect a statistically significant difference between the treatment groups on the composite cognitive memory score.
    2 context sentences
    Summary · context
    AL-108-211 was a placebo-controlled, ascending-dose study that explored the safety, tolerability and efficacy of 12 weeks of treatment with AL-108 in subjects with amnestic mild cognitive impairment.
    Summary · context
    A total of 144 subjects were randomized in a 2:1 drug:placebo ratio.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In amnestic mild cognitive impairment, AL-108 analyses identified potential efficacy signals in two memory and attention tests.

    In plain wordsIn people with amnestic mild cognitive impairment, AL-108 analyses found possible benefits versus placebo in two memory and attention tests.

    Peptide
    Davunetide
    Outcome
    Direction not reportedIndividual memory and attention tasks
    Study

    n = 144

    Comparator
    Placebo
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · intranasal · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Analyses of the individual cognitive tasks identified signals of potential efficacy in 2 tests of memory and attention.
    2 context sentences
    Summary · context
    AL-108-211 was a placebo-controlled, ascending-dose study that explored the safety, tolerability and efficacy of 12 weeks of treatment with AL-108 in subjects with amnestic mild cognitive impairment.
    Summary · context
    A total of 144 subjects were randomized in a 2:1 drug:placebo ratio.

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 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT00422981

Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment

Allon Therapeuticsn = 144Jan 2007 to Jan 2008

Mild Cognitive Impairment, So Stated

Trial pageClinicalTrials.govUpdated 24 Oct 2012

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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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