Using Digital Tools to Advance Alzheimer's Drug Trials During a Pandemic: The EU/US CTAD Task Force

Area of Science:

• Neurology
• Clinical Research Informatics
• Digital Health

Background:

• The COVID-19 pandemic significantly disrupted global Alzheimer's disease (AD) clinical studies.
• Digital technologies present a potential solution for remote assessment of cognitive and functional changes in AD.
• The EU/US Clinical Trials in Alzheimer's Disease (CTAD) Task Force convened to discuss digital technology integration in AD research.

Purpose of the Study:

• To explore the opportunities and challenges of using digital technologies in Alzheimer's disease clinical research.
• To assess the potential of digital tools to mitigate pandemic-related disruptions in AD trials.
• To provide recommendations on the future use of digital technologies in AD clinical studies.

Main Methods:

• Virtual meeting of the EU/US CTAD Task Force in November 2020.
• Discussion and analysis of the benefits and drawbacks of digital technologies in AD clinical research.
• Review of existing literature and expert opinions on digital data in clinical trials.

Main Results:

• Digital tools can accelerate trials, enhance participant diversity, capture meaningful data, and reduce costs.
• Concerns persist regarding the stability, validity, generalizability, and reproducibility of digital data.
• Regulatory acceptance and data privacy remain significant challenges for digital health solutions.

Conclusions:

• Further exploration of digital technologies through collaboration and data sharing is supported.
• Standardization of digital readouts is crucial for reliable data collection.
• Remote assessments may be feasible for non-invasive, multi-domain AD studies, but premature for novel medication trials.