Characterizing Real-World Data Availability for Monitoring Anti-Amyloid Therapy in Alzheimer’s Disease

Objectives
Anti-amyloid monoclonal antibodies have introduced new diagnostic and monitoring workflows in Alzheimer’s disease (AD), increasing the need for real-world data that reflect current clinical practice. This study characterized completeness and longitudinal availability of a curated real-world AD dataset from the Tempus Database for evaluating treatment monitoring and disease progression in routine care.

Methods
This descriptive study used a curated dataset of 500 de-identified patients in the Tempus Database with AD-spectrum diagnoses treated with lecanemab and/or donanemab. Data included treatment, imaging, cognitive assessments, functional measures, symptoms, fluid biomarkers, and APOE status. We evaluated completeness across domains, quantified analysis-ready cohorts using pre-specified data-availability definitions, and assessed repeated measurements relative to treatment initiation at baseline, 0-6 months, 6-12 months, and 12-18 months.

Results
Treatment exposure was available for all 500 patients; 62% received lecanemab, 31% donanemab, and 7% more than one anti-amyloid drug. At curation, 86% remained on treatment. Imaging was available for 93% of patients, including MRI (91%) and amyloid PET (57%). Cognitive assessments were commonly captured (MMSE 66%, MoCA 70%), as were FAQ (59%), symptom assessments (85%-90%), and ADL functional status (89%). Fluid biomarker data were available for 68% of patients and APOE genotype for 71%. A core clinical cohort requiring cognition, MRI, and function measures included 424 patients (85%); adding APOE and fluid biomarkers reduced this to 273 (55%). A practical longitudinal threshold of at least 2 brain images, at least 2 standardized assessments, and at least 1 fluid biomarker was met by 280 patients (56%). Among 398 patients with sufficient follow-up, imaging was captured at baseline and repeated within 6 months in 89%.

Conclusions
This real-world AD dataset from the Tempus Database includes substantial multimodal and longitudinal data for studying anti-amyloid treatment in routine practice. In addition to imaging and cognitive testing, functional measures may expand follow-up available for monitoring disease progression.