To present the Alzheimer’s disease (AD) − digital assessments suite (AD−DAS) and describe the proof of concept (POC) study to test feasibility and preliminary clinical validity in an ongoing multicenter, prospective pilot study in participants with subjective cognitive decline, early Alzheimer’s disease, and healthy controls. 

Clinical research and drug development in AD rely on accurate identification of cognitive and functional impairments, and the quantification of their progression over time. Remote smartphone-based measurements enable frequent and in-depth assessment of cognition and functioning but require validation against standard clinical outcomes and relevant biomarkers.

The AD−DAS comprises smartphone active tasks of cognitive and motor functioning, and passive monitoring of behavior in daily life measured. The multicenter international POC study is running in 2 countries across 5 sites with 120 participants. At screening and baseline, participants aged ≥65 underwent imaging (MRI, amyloid-PET), standard neuropsychological testing, and health-related assessments. For 28 days, participants remotely performed active smartphone tasks and surveys daily on the preconfigured study smartphone. Participant acceptability and perceived difficulty of the AD-DAS tasks were assessed using an end-of-study questionnaire.

Recruitment is ongoing. At the time of submission of this abstract, 109 participants were enrolled, of which 100 successfully completed the study and 2 discontinued. Preliminary results suggest good feasibility (~98%) and acceptance-based on a 5-point Likert scale. Adherence to the testing protocol was high (~96%). Clinical validity will be assessed when data collection is complete.

The AD-DAS aims to support identification of target populations and subgroups of fast progressors, to provide robust measures of disease progression, and to ultimately provide remote, clinically meaningful functional outcomes for observational and interventional drug trials in preclinical and early AD.