APOE-related risk of mild cognitive impairment and dementia for prevention trials: An analysis of four cohorts
Open accessAbstract
BACKGROUND: With the onset of prevention trials for individuals at high risk for Alzheimer disease, there is increasing need for accurate risk prediction to inform study design and enrollment, but available risk estimates are limited. We developed risk estimates for the incidence of mild cognitive impairment (MCI) or dementia among cognitively unimpaired individuals by APOE-e4 dose for the genetic disclosure process of the Alzheimer's Prevention Initiative Generation Study, a prevention trial in cognitively unimpaired APOE-e4/e4 homozygote individuals. METHODS AND FINDINGS: We included cognitively unimpaired individuals aged 60-75 y, consistent with Generation Study eligibility criteria, from the National Alzheimer's Coordinating Center (NACC) (n = 5,073, 158 APOE-e4/e4), the Rotterdam Study (n = 6,399, 156 APOE-e4/e4), the Framingham Heart Study (n = 4,078, 67 APOE-e4/e4), and the Sacramento Area Latino Study on Aging (SALSA) (n = 1,294, 11 APOE-e4/e4). We computed stratified cumulative incidence curves by age (60-64, 65-69, 70-75 y) and APOE-e4 dose, adjusting for the competing risk of mortality, and determined risk of MCI and/or dementia by genotype and baseline age. We also used subdistribution hazard regression to model relative hazard based on age, APOE genotype, sex, education, family history of dementia, vascular risk, subjective memory concerns, and baseline cognitive performance. The four cohorts varied considerably in age, education, ethnicity/race, and APOE-e4 allele frequency. Overall, cumulative incidence was uniformly higher in NACC than in the population-based cohorts. Among APOE-e4/e4 individuals, 5-y cumulative incidence was as follows: in the 60-64-y age stratum, it ranged from 0% to 5.88% in the three population-based cohorts versus 23.06% in NACC; in the 65-69-y age stratum, from 9.42% to 10.39% versus 34.62%; and in the 70-75-y age stratum, from 18.64% to 33.33% versus 38.34%. Five-year incidence of dementia was negligible except for APOE-e4/e4 individuals and those over 70 y. Lifetime incidence (to age 80-85 y) of MCI or dementia for the APOE-e4/e4 individuals in the long-term Framingham and Rotterdam cohorts was 34.69%-38.45% at age 60-64 y, 30.76%-40.26% at 65-69 y, and 33.3%-35.17% at 70-75 y. Confidence limits for these estimates are often wide, particularly for APOE-e4/e4 individuals and for the dementia outcome at 5 y. In regression models, APOE-e4 dose and age both consistently increased risk, as did lower education, subjective memory concerns, poorer baseline cognitive performance, and family history of dementia. We discuss several limitations of the study, including the small numbers of APOE-e4/e4 individuals, missing data and differential dropout, limited ethnic and racial diversity, and differences in definitions of exposure and outcome variables. CONCLUSIONS: Estimates of the absolute risk of MCI or dementia, particularly over short time intervals, are sensitive to sampling and a variety of methodological factors. Nonetheless, such estimates were fairly consistent across the population-based cohorts, and lower than those from a convenience cohort and those estimated in prior studies-with implications for informed consent and design for clinical trials targeting high-risk individuals.
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Among people age 65-69, based on data from a European study and a US study, the risk of developing dementia by the early to mid-80s was 5% to 7% among those with no copies of the e4 form, 15% to 16% among those with one copy, and 31% to 40% among those with two copies.
“For example, based on data from a study in Europe and a study in the United States, of people age 65‐69, the risk of developing dementia by the early to mid‐80s was 5% to 7% among those with no copies of the e4 form, 15% to 16% among those with one copy, and 31% to 40% among those with two copies.”
From 2024 Alzheimer's disease facts and figures (2024) · cites this paper as [82]
The Results (Stratified cumulative incidence estimates; page unavailable) identify the European Rotterdam Study and US Framingham Heart Study and report dementia-alone lifetime incidence of 5.26%–6.83% with no APOE-e4 copies and 30.76%–40.26% with two copies. The Abstract (Methods and findings; page unavailable) places the two-copy estimate in the 65–69 age group, with follow-up to age 80–85. The passages in our copy do not give the claimed 15%–16% estimate for one copy. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe lifetime risk up to age 80-85 years for mild cognitive impairment or dementia owing to Alzheimer disease has been estimated as 30-55% for APOEε4 homozygotes, 20-25% for APOEε3/ε4 carriers and 10-15% for APOEε3 homozygotes according to population-based studies with a majority of individuals of European ancestry.
“the lifetime risk up to age 80–85 years for mild cognitive impairment or dementia owing to AD has been estimated as 30–55% for APOEε4 homozygotes, 20–25% for APOEε3/ε4 carriers and 10–15% for APOEε3 homozygotes according to population-based studies with a majority of individuals of European ancestry17,18.”
From Multifaceted roles of APOE in Alzheimer disease (2024) · cites this paper as [17]
The Results (Stratified cumulative incidence estimates; page unavailable) report lifetime MCI-or-dementia incidence to age 80–85 in the population-based Rotterdam and Framingham cohorts, rising from 11.94%–15.57% with no APOE-ε4 copies to 37.47%–46.66% for ε4/ε4 homozygotes. But the cited passage groups people by ε4 dose rather than the specific ε3/ε3 and ε3/ε4 genotypes, does not give the quoted 20%–25% range, and does not restrict the outcome to impairment owing to Alzheimer disease. It also does not establish a 55% upper estimate for ε4/ε4 homozygotes. (LLM, conf=0.88)
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Benzodiazepine use and risk of incident MCI and dementia in a community sample
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Abraham, M., Seidenberg, M., Kelly, D. A., Nielson, K. A., Woodard, J. L., Smith, J. C., Durgerian, S., & Rao, S. M. (2020) · Journal of the International Neuropsychological Society · doi:10.1017/s1355617720000181 · Cited by 12 · see citing works
Early CA2 Tau Inclusions Do Not Distinguish an Age-Related Tauopathy from Early Alzheimer’s Disease
Tredici, K. D., Schön, M., Feldengut, S., Ghebremedhin, E., Kaufman, S. K., Wiesner, D., Roselli, F., Mayer, B., Amunts, K., & Braak, H. (2024) · Journal of Alzheimer s Disease · doi:10.3233/jad-240483 · Cited by 11 · see citing works
Brain health registry GenePool study: A novel approach to online genetics research
Fockler, J., Kwang, W., Ashford, M. T., Flenniken, D., Hwang, J. C., Truran, D., Mackin, R. S., Jin, C., O'Hara, R. M., Hallmayer, J. F., et al. (2021) · Alzheimer s & Dementia Translational Research & Clinical Interventions · doi:10.1002/trc2.12118 · Cited by 11 · see citing works
Factors associated with dropout in the longitudinal Vogel study of cognitive decline
Haberstumpf, S., Leinweber, J., Lauer, M., Polak, T. T., Deckert, J., & Herrmann, M. J. (2021) · European Journal of Neuroscience · doi:10.1111/ejn.15446 · Cited by 11 · see citing works
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Shah, S., Dounavi, M., Malhotra, P., LAWLOR, B. A., Naçi, L., Koychev, I. G., Ritchie, C. W., Ritchie, K. A., & O'Brien, J. T. (2024) · Brain Communications · doi:10.1093/braincomms/fcae046 · Cited by 11 · see citing works
Private payer coverage policies for ApoE-e4 genetic testing
Arias, J. J., Tyler, A. M., Douglas, M. P., & Phillips, K. A. (2021) · Genetics in Medicine · doi:10.1038/s41436-020-01042-4 · Cited by 11 · see citing works
Sárkány, Z., Damásio, J., Macedo‐Ribeiro, S., & Martins, P. M. (2025) · Alzheimer s & Dementia · doi:10.1002/alz.70213 · Cited by 10 · see citing works
Predicting Alzheimer's disease with practice effects, APOE genotype and brain metabolism
Oltra‐Cucarella, J., Sánchez‐SanSegundo, M., & Ferrer‐Cascales, R. (2022) · Neurobiology of Aging · doi:10.1016/j.neurobiolaging.2021.12.011 · Cited by 10 · see citing works
The role of Apolipoprotein E4 on cognitive impairment in Parkinson’s disease and Parkinsonisms
Rosal, A. E., Martin, S. L., & Strafella, A. P. (2025) · Frontiers in Neuroscience · doi:10.3389/fnins.2025.1515374 · Cited by 10 · see citing works
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- Authors
- Qian, J., Wolters, F. J., Beiser, A., Haan, M., Ikram, M. A., Karlawish, J., Langbaum, J. B., Neuhaus, J. M., Reiman, E. M., Roberts, J. S., Seshadri, S., Tariot, P. N., Woods, B. M., Betensky, R. A., & Blacker, D.
- Affiliations
- University of Massachusetts Amherst (US)
- Erasmus MC (NL)
- Boston University (US)
- University of California, San Francisco (US)
- University of Pennsylvania (US)
- Banner Alzheimer’s Institute (US)
- Translational Genomics Research Institute (US)
- University of Michigan (US)
- Harvard University (US)
- Corresponding author
- Blacker, Deborah
- ORCID
- Venue
- PLOS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2017-03-21
- Volume
- 14
- Issue
- 3
- Pages
- e1002254
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC5360223
- OpenAlex
- W2600450442
- Cited by
- 169
- References
- 74
- Citations by year
- 2026: 10 · 2025: 23 · 2024: 15 · 2023: 15 · 2022: 12 · 2021: 35 · 2020: 20 · 2019: 19 · 2018: 12 · 2017: 8
- FWCI
- 13.24
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, other-oa)
- UA Campus Repository (The University of Arizona) (acceptedVersion, cc-by)
- eScholarship (California Digital Library) (submittedVersion, cc-by)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion, cc-by)
- National University of Singapore (submittedVersion, cc-by)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- eScholarship (California Digital Library) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Funders
- National Institute on Aging (P30AG053760, P30AG010129, R01AG012975, U01AG016976, P30AG010124, R21AG053695, UF1AG046150, P30AG019610, P50AG005134, R01AG008122, P01AG036694)
- National Institute of Neurological Disorders and Stroke (R01NS017950)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Cognitive Abilities and Testing
- Keywords
- APOE ε4, Alzheimer's disease, mild cognitive impairment, dementia, risk prediction, cumulative incidence, cognitively unimpaired older adults, competing risk of death, family history of dementia, vascular risk
- MeSH terms
- Aged, Apolipoproteins E, Dementia, Female, Gene Frequency, Genotype, Humans, Male, Middle Aged, Netherlands, Risk Factors, United States, Cohort Studies, Cognitive Dysfunction
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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