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TRC-PAD: Accelerating Recruitment of AD Clinical Trials through Innovative Information Technology.

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Summary

The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease (TRC-PAD) Informatics Platform (TRC-PAD IP) streamlines participant selection for Alzheimer's trials. This secure, scalable platform efficiently identifies individuals with amyloid biomarkers for early-stage disease research.

Keywords:
Alzheimer’sclinical trialsinformaticsrecruitment

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Area of Science:

  • Neuroscience
  • Biomedical Informatics
  • Clinical Trials

Background:

  • The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease (TRC-PAD) program requires efficient participant management.
  • An informatics platform (TRC-PAD IP) was developed to support these needs.

Purpose of the Study:

  • To describe the innovative architecture, workflows, and components of the TRC-PAD IP.
  • To facilitate high-throughput, cost-effective selection, recruitment, and assessment of study participants.
  • To develop a learning algorithm for selecting amyloid-bearing participants for early Alzheimer's disease trials.

Main Methods:

  • Developed a secure, scalable, multi-tiered information management platform (TRC-PAD IP).
  • Integrated web-based and in-person assessments to predict amyloid biomarker abnormalities and trial eligibility.
  • Utilized longitudinal remote assessments of cognitive performance and memory concerns.
  • Employed positron emission tomography (PET) or lumbar puncture (LP) for amyloid biomarker confirmation.

Main Results:

  • The TRC-PAD IP successfully supported growth in participant recruitment, screening, and enrollment.
  • Leveraged a secure, scalable, cloud-based IT architecture for efficient operations.
  • Demonstrated cost-effectiveness in managing participant data and trial logistics.

Conclusions:

  • The TRC-PAD program and its informatics infrastructure (TRC-PAD IP) are feasible.
  • The platform's flexible and modular design can incorporate emerging diagnostic technologies.
  • The TRC-PAD IP effectively supports the aims of preclinical and prodromal Alzheimer's disease research.