Real-World Patient Eligibility for Alzheimer's Disease Anti-Amyloid Therapy in Seven Swedish Memory Clinics.

Abstract

Background: Anti-amyloid therapies lecanemab and donanemab are the first potentially disease-modifying treatments for Alzheimer's disease (AD) approved in Europe. We estimated real-world eligibility for these treatments in a large multicenter memory clinic patient cohort in Sweden (MemClin).

Methods: MemClin included patients with a first diagnostic visit between 2016 and 2022 at seven specialist memory clinics in Stockholm, Sweden. To estimate eligibility for anti-amyloid therapy, we applied key inclusion/exclusion criteria from the lecanemab and donanemab appropriate use recommendations. Eligible patients were required to have (1) a clinical diagnosis of AD-type dementia or mild cognitive impairment (MCI), (2) confirmed Aβ pathology (abnormal CSF Aβ42) and (3) no apparent medical exclusion criteria. Eligibility was calculated for different scenarios to provide both upper-bound estimates (main analysis) and more conservative, implementation-ready estimates of near-term treatable patients (sensitivity analysis).

Results: Cohort consisted of 2126 patients (mean age 77.1 ± 6.6 years; 61.8% MCI, 24.2% dementia, 13.7% subjective cognitive impairment). In the main analysis, 11.5% of the whole cohort was estimated to be eligible for either treatment (lecanemab 10.6%, donanemab 11.5%). Most eligible patients had early-stage disease (61.9% MCI vs. 38.1% dementia) and an A + T- biomarker profile, that is, normal biomarker of tau (57.9%). Eligibility was markedly lower in sensitivity analyses (e.g., 2.7% when all patients without MRI were assumed ineligible).

Conclusions: Even upper-bound estimates indicate that a minority of real-world memory clinic patients may currently qualify for anti-amyloid therapy. These findings provide timely evidence to inform the ongoing debate on the implementation of anti-amyloid therapy in public healthcare.