Eligibility for Anti-Amyloid Treatment in a Population-Based Study of Cognitive Aging
Open accessAbstract
BACKGROUND AND OBJECTIVES: Treatment options for Alzheimer disease (AD) are limited and have focused mainly on symptomatic therapy and improving quality of life. Recently, lecanemab, an anti-β-amyloid monoclonal antibody (mAb), received accelerated approval by the US Food and Drug Administration for treatment in the early stages of biomarker-confirmed symptomatic AD. An additional anti-β-amyloid mAb, aducanumab, was approved in 2021, and more will potentially become available in the near future. Research on the applicability and generalizability of the anti-β-amyloid mAb eligibility criteria on adults with biomarkers available in the general population has been lacking. The study's primary aim was to apply the clinical trial eligibility criteria for lecanemab treatment to participants with early AD of the population-based Mayo Clinic Study of Aging (MCSA) and assess the generalizability of anti-amyloid treatment. The secondary aim of this study was to apply the clinical trial eligibility criteria for aducanumab treatment in MCSA participants. METHODS: This cross-sectional study aimed to apply the clinical trial eligibility criteria for lecanemab and aducanumab treatment to participants with early AD of the population-based MCSA and assess the generalizability of anti-amyloid treatment. RESULTS: Two hundred thirty-seven MCSA participants (mean age [SD] 80.9 [6.3] years, 54.9% male, and 97.5% White) with mild cognitive impairment (MCI) or mild dementia and increased brain amyloid burden by PiB PET comprised the study sample. Lecanemab trial's inclusion criteria reduced the study sample to 112 (47.3% of 237) participants. The trial's exclusion criteria further narrowed the number of potentially eligible participants to 19 (overall 8% of 237). Modifying the eligibility criteria to include all participants with MCI (instead of applying additional cognitive criteria) resulted in 17.4% of participants with MCI being eligible for lecanemab treatment. One hundred four participants (43.9% of 237) fulfilled the aducanumab clinical trial's inclusion criteria. The aducanumab trial's exclusion criteria further reduced the number of available participants, narrowing those eligible to 12 (5.1% of 237). Common exclusions were related to other chronic conditions and neuroimaging findings. DISCUSSION: Findings estimate the limited eligibility in typical older adults with cognitive impairment for anti-β-amyloid mAbs.
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Only 8% of a sample of adults with dementia or MCI and a positive brain amyloid PET scan would meet the lecanemab clinical trial inclusion and exclusion criteria.
“only 8% of the sample would meet the lecanemab clinical trial inclusion and exclusion criteria. 968”
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- Authors
- Pittock, R. R., Aakre, J. A., Castillo, A. M., Ramanan, V. K., Kremers, W. K., Jack, C. R., Vemuri, P., Lowe, V. J., Knopman, D. S., Petersen, R. C., Graff-Radford, J., & Vassilaki, M.
- Affiliations
- Mayo Clinic (US)
- From the Department of Neurology (R.R.P., V.K.R., D.S.K., R.C.P., J.G.-R.), Mayo Clinic, Rochester, MN; The College (R.R.P.), University of Chicago, IL; Departments of Quantitative Health Sciences (J.A.A., A.M.C., W.K.K., R.C.P., M.V.) and Radiology (C.R.J., P.V., V.J.L.), Mayo Clinic, Rochester, MN.
- Corresponding author
- Vassilaki, Maria
- ORCID
- Venue
- Neurology
- Published
- 2023-11-07
- Volume
- 101
- Issue
- 19
- Pages
- e1837-e1849
- ISSN
- 0028-3878 (ISSN-L)
- 1526-632X
- PMC
- PMC10663008
- OpenAlex
- W4385854855
- Cited by
- 151
- References
- 43
- Citations by year
- 2026: 40 · 2025: 44 · 2024: 59 · 2023: 8
- FWCI
- 26.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Neurology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Mayo Clinic (AG 058738, P30 AG062677, U01 AG006786)
- Abbott Laboratories
- Amgen
- Mayo Foundation for Medical Education and Research
- GHR Foundation
- University of Oxford
- National Institutes of Health (AG062677, AG011378)
- National Institute on Aging (R21AG058738, AG041851, AG011378, U01AG006786, AG-006786, 058738, AG058738, R33AG058738, R01AG041851, R37AG011378, P30AG062677)
- National Cancer Institute
- National Institute of Neurological Disorders and Stroke (R01NS097495)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
- Keywords
- Alzheimer's disease, anti-amyloid monoclonal antibodies, lecanemab, aducanumab, treatment eligibility criteria, inclusion and exclusion criteria, mild cognitive impairment, mild dementia, amyloid PET, PiB PET, Mayo Clinic Study of Aging, generalizability of trial results, early Alzheimer's disease, exclusion criteria, chronic disease, neuroimaging
- MeSH terms
- Cognitive Aging, Aged, Alzheimer Disease, Amyloid, Child, Cross-Sectional Studies, Female, Humans, Male, Quality of Life, Amyloid beta-Peptides, Cognitive Dysfunction
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