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Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.

J Cummings1, P Aisen2, R Barton3

  • 1Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.

The Journal of Prevention of Alzheimer'S Disease
|May 2, 2017
PubMed
Summary

The Global Alzheimer Platform (GAP) initiative, including GAP-NET, aims to improve Alzheimer's disease (AD) clinical trials through standardized sites and efficient recruitment. This accelerates the development and availability of new AD treatments.

Keywords:
Alzheimer’s diseaseGlobal Alzheimer Platformcertificationclinical trialsdrug developmentdrug discoveryrecruitmentregistry

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Area of Science:

  • Neuroscience
  • Clinical Trials
  • Drug Development

Background:

  • Alzheimer's disease (AD) drug development faces significant challenges including high costs, long timelines, and inefficiency.
  • Key areas needing improvement include trial site operations, clinical trial design, and patient recruitment.

Purpose of the Study:

  • To introduce the Global Alzheimer Platform (GAP) and its work streams designed to address inefficiencies in AD drug development.
  • To detail the GAP-NET initiative, focused on establishing a standardized network of qualified clinical trial sites.

Main Methods:

  • The GAP initiative comprises four work streams: registry-to-cohort recruitment, clinical trial site network construction (GAP-NET), adaptive trial design, and finance.
  • GAP-NET aims to create a network of continuously funded, highly qualified trial sites with established capabilities in clinical assessment, biomarkers, and imaging.
  • Standardized protocols, certified raters, and robust management systems will be implemented across the GAP-NET sites.

Main Results:

  • GAP-NET will conduct trials for academic and industry partners, leveraging collaborations with international initiatives like EPAD and CCNA for global reach.
  • The initiative is projected to enhance trial efficiency and quality, reduce redundancy, accelerate recruitment, and lower overall trial costs.
  • Value is provided to sites through stable funding and uniform training, to sponsors via reduced costs and timelines, and to patients through faster access to treatments.

Conclusions:

  • The GAP and GAP-NET initiatives represent a strategic approach to overcome critical barriers in Alzheimer's disease clinical research.
  • By standardizing trial site operations and improving recruitment, these programs aim to accelerate the delivery of effective therapies for AD patients.