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Alzheimer’s disease therapeutic trials: EU/US task force report on recruitment, retention, and methodology

  • JNHA: Clinical Trials and Aging
  • Published:
The journal of nutrition, health & aging

Abstract

While we may not be able to find a cure for Alzheimer’s disease (AD) in the near future, several drugs presently in trials have shown promise as possible modifiers of disease progression. However, we may not be able to demonstrate efficacy due to issues of recruitment, retention, site-to-site variability, and other methodological issues. It is thus incumbent on the scientific community to find solutions to these problems, particularly as the field moves toward preventing illness or treating the disease in its prodromal stages, where these methodological issues will become even more critical. We need to better understand why participants agree or refuse to enter drag trials, and why both primary care physicians and Alzheimer’s specialists agree or refuse to involve their patients. We also need to quantify the impact of requiring imaging studies, extensive questionnaires, cognitive testing, and lumbar punctures on recruitment and retention. With these concerns in mind, an international task force meeting of experts from academia and industry in the United States, European Union, and Japan in San Diego, California on November 2, 2011 to focus on recruitment, retention and other methodological issues related to clinical trials for AD. Based on the recommendations of this Task force meeting, this Perspectives article critically reflects on the most critical and timely methodological issues related to recruitment and retention in prevention and therapeutic trials in AD, which are paralleled by a paradigm shift in the diagnostic conceptualization of this disease, as reflected by recently new proposed diagnostic criteria involving preclinical stages of the disease.

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Authors and Affiliations

  1. Inserm, U558, F-31073, Toulouse, France

    B. Vellas & S. Andrieu

  2. Univ, Toulouse III, Toulouse, F-31073, France

    B. Vellas & S. Andrieu

  3. Department of Psychiatry, Psychosomatic Medicine & Psychotherapy, Goethe University, Frankfurt, Germany

    H. Hampel

  4. Department of Family Medicine, University of Toulouse, Toulouse, France

    M. E. Rouge-Bugat

  5. Global R&D Partners, LLC, San Diego, CA, USA

    M. Grundman

  6. Elan Pharmaceuticals, Inc., South San Francisco, CA, 94080, USA

    S. Abu-Shakra

  7. Washington University School of Medicine, Washington, USA

    R. Bateman & J. Morris

  8. Bristol-Myers Squibb, Wallingford, CT, 06492, USA

    R. Berman

  9. Pfizer, Inc., Collegeville, PA, 19426, USA

    R. Black

  10. Alzheimer’s Association, Chicago, IL, USA

    M. Carrillo

  11. University of California, San Diego, La Jolla, CA, 92093, USA

    M. Donohue

  12. Avid Radiopharmaceuticals, Inc., Philadelphia, PA, 19104, USA

    M. Mintun

  13. Mayo Clinic, Rochester, MN, 55905, USA

    R. Petersen

  14. Departments of Family and Preventive Medicine, and Neurosciences, University of California, La Jolla, CA, 92093, USA

    R. G. Thomas

  15. SYNARC, Newark, CA, 94560, USA

    J. Suhy

  16. University of Southern California Keck School of Medicine, Los Angeles, CA, 90033, USA

    L. Schneider

  17. Medication, Inc., San Francisco, CA, 94105, USA

    L. Seely

  18. Banner Alzheimer’s Institute, Phoenix, AZ, 85006, USA

    P. Tariot

  19. University of Arizona College of Medicine, Phoenix, AZ, 85006, USA

    P. Tariot

  20. University Hospital of Montpellier, 34025, Montepellier Cedex 5, France

    J. Touchon

  21. Center for Imaging of Neurodegenerative Disease, VA Medical Center, University of California San Francisco, San Francisco, CA, USA

    M. Weiner

  22. CHDI Foundation, Inc., Princeton, NJ, 08540, USA

    C. Sampaio

  23. Department of Neurosciences, University of California, San Diego, San Diego, CA, USA

    P. Aisen

Authors
  1. B. Vellas
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  2. H. Hampel
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  3. M. E. Rouge-Bugat
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  4. M. Grundman
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  5. S. Andrieu
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  6. S. Abu-Shakra
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  7. R. Bateman
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  8. R. Berman
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  9. R. Black
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  10. M. Carrillo
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  11. M. Donohue
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  12. M. Mintun
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  13. J. Morris
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  14. R. Petersen
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  15. R. G. Thomas
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  16. J. Suhy
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  17. L. Schneider
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  18. L. Seely
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  19. P. Tariot
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  20. J. Touchon
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  21. M. Weiner
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  22. C. Sampaio
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  23. P. Aisen
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authors contributed equally to this manuscript

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Vellas, B., Hampel, H., Rouge-Bugat, M.E. et al. Alzheimer’s disease therapeutic trials: EU/US task force report on recruitment, retention, and methodology. J Nutr Health Aging 16, 339–345 (2012). https://doi.org/10.1007/s12603-012-0044-x

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  • DOI: https://doi.org/10.1007/s12603-012-0044-x

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