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Drug Development.

Jeffrey A Kaye1,2,3, Alex B Speers1,3, Amanda B Mar1,2,3

  • 1Oregon Health & Science University, Portland, OR, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
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Digital biomarkers (DBs) show promise for detecting Alzheimer's disease (AD) changes in clinical trials. Baseline measurements in the DETECT-AD study found no significant differences in DBs between amyloid-positive and amyloid-negative participants.

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Area of Science:

  • Neurology
  • Biomarkers
  • Clinical Trials

Background:

  • Conventional Alzheimer's disease (AD) clinical trials struggle with sensitive detection of subtle changes in early stages.
  • Digital biomarkers (DBs) offer objective, continuous, and unobtrusive monitoring in real-world settings.
  • Evidence is needed on home-based DBs detecting meaningful changes related to amyloid (Aβ) burden in pre-symptomatic and prodromal AD.

Purpose of the Study:

  • To evaluate the utility of continuously assessed, home-based digital biomarkers (DBs) in detecting clinically meaningful changes in individuals with varying amyloid (Aβ) burdens.
  • To establish baseline data for the simulated DETECT-AD clinical trial, comparing Aβ-positive and Aβ-negative participants.
  • To assess the integration of DBs into anti-amyloid therapeutic trial designs.

Main Methods:

  • Enrollment of pre-symptomatic and prodromal AD patients stratified by Aβ Florbetapir-PET status into Aβ-positive (n=50) and Aβ-negative (n=50) groups.
  • Collection of baseline clinical, fluid biomarker, MRI, PET, and digital biomarker data using passive and active sensors.
  • Primary outcome: change in a composite DB score across mobility, cognition, sleep, and socialization domains.

Main Results:

  • Full enrollment (n=103) achieved, with baseline characteristics presented.
  • Design-based differences observed in amyloid-beta (Aβ) levels (SUVR) between groups.
  • No significant differences in digital biomarkers (DBs) were detected between Aβ-positive and Aβ-negative groups during the baseline period.

Conclusions:

  • Digital biomarkers (DBs) can be effectively integrated into clinical trials targeting anti-amyloid therapies.
  • Stable baseline DB measures between Aβ-positive and Aβ-negative groups provide a foundation for future detection of divergent trajectories.
  • This study sets the stage for future research on the sensitivity of DBs in tracking disease progression and treatment effects in Alzheimer's disease.