The Case for Using Actigraphy Generated Sleep and Activity Endpoints in Alzheimer's Disease Clinical Trials

Area of Science:

• Digital health
• Clinical trial technology
• Biomedical engineering

Background:

• Consumer wearables and smartphones are increasingly used for health and fitness monitoring.
• Integrating these technologies into clinical trials requires validation and regulatory compliance.
• Traditional data collection methods in trials can be burdensome and prone to variability.

Purpose of the Study:

• To explore the relevance and application of validated wearable technology in drug development.
• To highlight the potential of wearables to capture objective outcome measures with reduced patient burden.
• To demonstrate the utility of wearables in challenging therapeutic areas, such as Alzheimer's disease.

Main Methods:

• Review of current trends in wearable technology for health monitoring.
• Discussion of regulatory considerations for clinical trial technology.
• Case example: application of wearables in Alzheimer's disease drug development studies.

Main Results:

• Validated wearables can provide objective, continuous data, overcoming limitations of self-reported outcomes.
• Wearable technology can potentially reduce patient and site staff burden in clinical trials.
• Application in Alzheimer's disease trials can address challenges with patient compliance and rater variability.

Conclusions:

• Validated wearable devices present a significant opportunity to enhance clinical trial efficiency and data quality.
• The use of wearables can lead to more objective and reliable outcome measures, particularly in neurodegenerative diseases.
• Addressing regulatory requirements is key to unlocking the full potential of wearables in pharmaceutical research.