The journal of nutrition, health & aging

, Volume 16, Issue 4, pp 339–345

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

  • B. Vellas
  • H. Hampel
  • M. E. Rouge-Bugat
  • M. Grundman
  • S. Andrieu
  • S. Abu-Shakra
  • R. Bateman
  • R. Berman
  • R. Black
  • M. Carrillo
  • M. Donohue
  • M. Mintun
  • J. Morris
  • R. Petersen
  • R. G. Thomas
  • J. Suhy
  • L. Schneider
  • L. Seely
  • P. Tariot
  • J. Touchon
  • M. Weiner
  • C. Sampaio
  • P. Aisen
  • Task Force Participants
JNHA: Clinical Trials and 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.

Key words

Alzheimer’s disease biomarkers neuroimaging 

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Copyright information

© Serdi and Springer Verlag France 2012

Authors and Affiliations

  • B. Vellas
    • 1
    • 2
  • H. Hampel
    • 3
  • M. E. Rouge-Bugat
    • 4
  • M. Grundman
    • 5
  • S. Andrieu
    • 1
    • 2
  • S. Abu-Shakra
    • 6
  • R. Bateman
    • 7
  • R. Berman
    • 8
  • R. Black
    • 9
  • M. Carrillo
    • 10
  • M. Donohue
    • 11
  • M. Mintun
    • 12
  • J. Morris
    • 7
  • R. Petersen
    • 13
  • R. G. Thomas
    • 14
  • J. Suhy
    • 15
  • L. Schneider
    • 16
  • L. Seely
    • 17
  • P. Tariot
    • 18
    • 19
  • J. Touchon
    • 20
  • M. Weiner
    • 21
  • C. Sampaio
    • 22
  • P. Aisen
    • 23
  • Task Force Participants
  1. 1.Inserm, U558ToulouseFrance
  2. 2.Univ, Toulouse IIIToulouseFrance
  3. 3.Department of Psychiatry, Psychosomatic Medicine & PsychotherapyGoethe UniversityFrankfurtGermany
  4. 4.Department of Family MedicineUniversity of ToulouseToulouseFrance
  5. 5.Global R&D Partners, LLCSan DiegoUSA
  6. 6.Elan Pharmaceuticals, Inc.South San FranciscoUSA
  7. 7.Washington University School of MedicineWashingtonUSA
  8. 8.Bristol-Myers SquibbWallingfordUSA
  9. 9.Pfizer, Inc.CollegevilleUSA
  10. 10.Alzheimer’s AssociationChicagoUSA
  11. 11.University of California, San DiegoLa JollaUSA
  12. 12.Avid Radiopharmaceuticals, Inc.PhiladelphiaUSA
  13. 13.Mayo ClinicRochesterUSA
  14. 14.Departments of Family and Preventive Medicine, and NeurosciencesUniversity of CaliforniaLa JollaUSA
  15. 15.SYNARCNewarkUSA
  16. 16.University of Southern California Keck School of MedicineLos AngelesUSA
  17. 17.Medication, Inc.San FranciscoUSA
  18. 18.Banner Alzheimer’s InstitutePhoenixUSA
  19. 19.University of Arizona College of MedicinePhoenixUSA
  20. 20.University Hospital of MontpellierMontepellier Cedex 5France
  21. 21.Center for Imaging of Neurodegenerative Disease, VA Medical CenterUniversity of California San FranciscoSan FranciscoUSA
  22. 22.CHDI Foundation, Inc.PrincetonUSA
  23. 23.Department of NeurosciencesUniversity of California, San DiegoSan DiegoUSA

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