Aims: Emerging disease-modifying treatments for Alzheimer’s disease (AD) have received approval by the Australian Therapeutic Goods Administration2. Lecanemab, an anti-β amyloid monoclonal antibody (mAb)1, was approved for treatment of early-stage biomarker-positive symptomatic AD2. There is limited research on the applicability and generalisability of the anti-β amyloid mAb eligibility criteria3 and Appropriate Use Criteria (AUR)5 in the Australian population. We aim to apply the clinical trial eligibility criteria for Lecanemab treatment4 to a CDAMS patient cohort, in the absence of amyloid biomarker-positivity and apolipoprotein-E ε4 (ApoE ε4) status. The secondary aim is to compare the characteristics of the eligible and non-eligible groups.
Methods: A retrospective cohort study was conducted. We applied the clinical trial eligibility criteria for lecanemab4 treatment to CDAMS patients seen November 2021 to May 2023 at Western Health, a large tertiary hospital in Melbourne, Australia.
Results: The sample comprised 205 CDAMS patients with mild cognitive impairment (MCI) (30.7%) and AD dementia (69.3%). The mean age was 78±6.5 years and 62% were female. Only 70 (34.1%) individuals met lecanemab trial inclusion criteria4. The number of potentially eligible individuals was further reduced to 30 (14%) after applying the trial’s exclusion criteria. Applying the AUR5 resulted in 25 (12.2%) individuals with MCI and AD dementia being potentially eligible (before confirmatory biomarker testing for lecanemab treatment).
Conclusions: Findings suggest that there is limited eligibility for anti-amyloid therapy in a real-world patient cohort of older adults.