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

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

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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Crossref · 10.1159/000348347

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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)
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
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 · 2012: 2
FWCI
5.11
Type
journal article
Language
en
Open access
closed
Locations
  • Dementia and Geriatric Cognitive Disorders (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Pharmacology › 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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