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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
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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“The microtubule-stabilizing agent davunetide was studied in a phase 2 trial but it did not meet the clinical end points.85”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [85]
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Metadata
- 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
- FWCI
- 5.11
- Type
- journal article
- Language
- en
- Open access
- closed
- 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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