Mibampator (LY451395) randomized clinical trial for agitation/aggression in Alzheimer's disease
Open accessAbstract
BACKGROUND: Mibampator, an amino-3-hydroxy-5-methyl-4-isoxazole propionic acid receptor potentiator, was evaluated for treatment of agitation and aggression (A/A) in Alzheimer's disease (AD). METHODS: Outpatients (n = 132) with probable AD and A/A randomized to 12 weeks of double-blind treatment with 3-mg po mibampator or placebo were assessed using the 4-domain A/A subscale of the Neuropsychiatric Inventory (NPI-4-A/A) derived from the Neuropsychiatric Inventory. Secondary measures included the Cohen-Mansfield Agitation Inventory, Cornell Scale for Depression in Dementia, Frontal Systems Behavior Inventory (FrSBe), and Alzheimer's Disease Assessment Scale-Cognitive. Efficacy was analyzed using mixed-effects model repeated measures from baseline to endpoint. Adverse events (AEs), labs, vital signs, and electrocardiograms were monitored. RESULTS: Baseline characteristics were comparable between groups. Both groups improved on the NPI-4-A/A, but without group differences. Among secondaries, mibampator was significantly better (p = 0.007) than placebo only on the FrSBe. AEs were similar between groups. One death occurred in the placebo group. CONCLUSION: Possible explanations for no significant group differences include caregiver, drug target engagement, and design issues. This trial is registered on ClinicalTrials.gov; ID: NCT00843518.
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AMPAR PAMs appeared well-tolerated in early-phase clinical trials, but failures to improve cognition and mood have consistently been observed.
“While AMPAR PAMs appeared to be well-tolerated in earlyphase clinical trials, failures to improve cognition and mood have consistently been observed [201,202]”
From Ketamine in neuropsychiatric disorders: an update (2024) · cites this paper as [202]
The Results (Safety evaluation; page not provided) say mibampator was well tolerated. The Results (Efficacy; page not provided) report no treatment-group advantage on the cognitive measure or depression scale, although apathy improved significantly with mibampator. This trial of one AMPA receptor potentiator does not establish that failures to improve cognition and mood were consistently observed across AMPAR PAMs. (LLM, conf=0.86)
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- Authors
- Trzepacz, P. T., Cummings, J., Konechnik, T., Forrester, T. D., Chang, C., Dennehy, E. B., Willis, B. A., Shuler, C., Tabas, L. B., & Lyketsos, C.
- Affiliations
- Eli Lilly (United States) (US)
- Cleveland Clinic (US)
- Johns Hopkins University (US)
- Corresponding author
- Trzepacz, Paula T.
- Venue
- International Psychogeriatrics
- Publisher
- Elsevier BV
- Published
- 2013-05
- Volume
- 25
- Issue
- 5
- Pages
- 707-719
- ISSN
- 1041-6102 (ISSN-L)
- PMC
- PMC3938603
- OpenAlex
- W2084820245
- Cited by
- 53
- References
- 53
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 3 · 2023: 4 · 2022: 2 · 2021: 5 · 2020: 5 · 2019: 4 · 2018: 5 · 2017: 4 · 2016: 1 · 2015: 9 · 2014: 4 · 2013: 1
- FWCI
- 3.19
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- International Psychogeriatrics (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Eli Lilly and Company
- National Institute on Aging (P50AG005146)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neuroscience and Neuropharmacology Research
- Keywords
- Alzheimer's disease, agitation, aggression, NMDA receptor antagonists, neuropsychiatric symptoms, Neuropsychiatric Inventory, depression in dementia, adverse events
- MeSH terms
- Aged, Aged, 80 and over, Aggression, Alzheimer Disease, Biphenyl Compounds, Double-Blind Method, Female, Humans, Male, Middle Aged, Neuropsychological Tests, Outpatients, Psychomotor Agitation, Surveys and Questionnaires, Sulfonamides, Treatment Outcome
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