Cited by 115Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative Diseases

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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, Bruce H., Schmechel, Don, Hirman, Joe, Blackwell, Andrew, Keith, Julian, Gold, Michael, on behalf of the AL-108-211 Study Investigators·2013·Dementia and Geriatric Cognitive Disorders

DOI 10.1159/000348347

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Abstract

Background/Aims: 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. Methods: A total of 144 subjects were randomized in a 2:1 drug:placebo ratio. Subjects were enrolled into the low-dose group or placebo and then to the high-dose group or placebo. Pooling of the placebo groups yielded 3 groups (approx. 48/group) whose baseline demographics and disease characteristics were well matched. Results: AL-108 was generally safe and well tolerated. Analyses of efficacy data failed to detect a statistically significant difference between the treatment groups on the composite cognitive memory score. Analyses of the individual cognitive tasks identified signals of potential efficacy in 2 tests of memory and attention. Conclusion: These data suggest that AL-108 was generally safe, well tolerated and merits additional investigation as a treatment for Alzheimer's disease.

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Authors: Morimoto, B. H., Schmechel, D., Hirman, J., Blackwell, A., Keith, J., Gold, M., & on behalf of the AL-108-211 Study Investigators
Affiliations: Cambridge Cognition (United Kingdom) (GB)
University of North Carolina Wilmington (US)
ORCID: Blackwell, Andrew
Keith, Julian
Venue: Dementia and Geriatric Cognitive Disorders
Publisher: S. Karger AG
Published: 2013
Volume: 35
Issue: 5-6
Pages: 325-339
ISSN: 1420-8008 (ISSN-L)
1421-9824
DOI: 10.1159/000348347
OpenAlex: W2084247881
Cited by: 115
References: 37
Citations by year: 2026: 5 · 2025: 11 · 2024: 5 · 2023: 10 · 2022: 7 · 2021: 12 · 2020: 14 · 2019: 14 · 2018: 7 · 2017: 6 · 2016: 9 · 2015: 5 · 2014: 5 · 2013: 3
FWCI: 5.11
Type: journal article
Language: en
Open access: closed
Licence: www.karger.com/Services/SiteLicenses (vor)
www.karger.com/Services/SiteLicenses (tdm)
Locations: Dementia and Geriatric Cognitive Disorders (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
Keywords: amnestic mild cognitive impairment, Alzheimer's disease, intranasal administration, cognitive memory, attention, drug safety and tolerability, cognitive impairment treatment
MeSH terms: Administration, Intranasal, Aged, Aged, 80 and over, Cognition, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Memory, Short-Term, Middle Aged, Neuropsychological Tests, Oligopeptides, Paired-Associate Learning, Patient Compliance, Space Perception, Cognitive Dysfunction

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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

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