4,068 posters, 219 videos, 101 topics, 69 sessions, 14,365 authors, 6,128 institutions

Alzheimer's Association International Conference 2026

July 12-15, 2026 | London, United Kingdom, and Online

1750

Clinical Complexity In MCI And AD: A Real-world Study Of Comorbidities And Medication Use In The US (Medicare)

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Poster Presenter

Paola Nasuti

Authors

Paola Nasuti, Sally Lee, Helena Roque, Yu Han

Affiliations

UCB, Slough, UK, UCB, Brussels, Belgium, Genesis Research Group, Hoboken, NJ, USA

Part of Topic

Background:

Clinical trials and patient registries often exclude individuals with certain comorbid conditions or on specific medications, thereby limiting generalisability to broader real‐world patient populations.¹ As a result, trial participants may differ substantially from individuals seen in routine clinical practice in terms of age, comorbidity burden, concomitant medication use and disease severity.

Objective:

To estimate the prevalence of selected comorbid conditions and medication use* that are commonly applied as exclusion criteria in clinical trials and disease registries, in individuals newly diagnosed with mild cognitive impairment/Alzheimer’s disease (MCI/AD), in the 12 months prior to, and including, the diagnosis date of MCI or AD.

Methods:

•This retrospective, observational cohort study used US CMS Medicare Fee-for-Service claims data, covering individuals aged ≥65 years and younger individuals with disabilities. The data source represents the US population covered by Medicare Fee-for-Service across all states.

•Individuals aged 50–80 years with a first recorded MCI or AD diagnosis between 1 January 2019 and 31 December 2022 were eligible (Figure 1).

•Selected comorbidities (defined as ≥1 relevant ICD-10-CM code) and treatments of interest were ascertained over the Baseline period (Figure 2).

•For inclusion, all individuals required ≥12 months of continuous medical and pharmacy enrolment before and after the index date, with no prior MCI/AD diagnosis during the washout window.

•A sensitivity analysis with an extended Baseline period to include all prior data between enrolment and the index date was conducted to verify comorbidity estimates and minimise misclassification of prevalent cases.

Results:

•A total of 460,775 individuals with newly diagnosed MCI/AD (62.5% MCI; 36.9% AD; 0.6% both MCI and AD) met the eligibility criteria (58.3% female; 41.7% male); Baseline demographics and clinical characteristics are in Table 1.

•Overall, 78.6% of individuals had ≥1 of the comorbidities investigated; 50.6% had two or more and 27.9% had three or more.

•At Baseline, 49.1% of individuals had ≥1 psychiatric disorder (Figure 2A), 16.0% had ≥1 neurological disorder (Figure 2B), 38.1% had ≥1 cardiovascular condition (Figure 2C)
and 37.4% had ≥1 other disorders (Figure 2D).

•At Baseline, 23.5% of individuals were receiving anticoagulant and/or antiplatelet therapy (Figure 3).

•Sensitivity analyses demonstrated that comorbidity prevalence estimates were broadly consistent across specifications, except for malignancy, where some variation was observed.

Study limitations:

•Analyses using real-world data rely on predefined algorithms and definitions to identify MCI/AD cases and comorbidities. Although consistent definitions were applied throughout
the study, the sensitivity of the claims-based algorithm is unlikely to be 100% due to the inherent limitations of claims data, which may result in some cases or comorbidities being missed or misclassified.

•Diagnosis codes did not allow differentiation between uncontrolled comorbidities, which are typically used as trial and disease registry exclusion criteria, and well-controlled comorbidities.

Conclusions:

The majority of individuals with MCI/AD (78.6%; mean age 73 years) had ≥1 major selected comorbidity—often a condition that would exclude them from clinical trials or disease registries. This finding reflects the complex, multi-morbid profile of MCI/AD in routine care, and it underscores the need for caution when generalising trial results to everyday practice.

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