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, Ronald Carl Petersen, R. G. Thomas, J. Suhy, L. Schneider, L. Seely, P. Tariot, J. TouchonM. Weiner, C. Sampaio, P. Aisen

Research output: Contribution to journalArticle

25 Citations (Scopus)

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, articularly 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 drug 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.

Original languageEnglish (US)
Pages (from-to)339-345
Number of pages7
JournalJournal of Nutrition, Health and Aging
Volume16
Issue number4
DOIs
StatePublished - Apr 2012

Fingerprint

Advisory Committees
Alzheimer Disease
Prodromal Symptoms
Spinal Puncture
Primary Care Physicians
European Union
Pharmaceutical Preparations
Disease Progression
Industry
Japan
Therapeutics
Clinical Trials

Keywords

  • Alzheimer's disease
  • Biomarkers
  • Neuroimaging

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics
  • Geriatrics and Gerontology

Cite this

Vellas, B., Hampel, H., Rouge-Bugat, M. E., Grundman, M., Andrieu, S., Abu-Shakra, S., ... Aisen, P. (2012). Alzheimer's disease therapeutic trials: Eu/us task force report on recruitment, retention, and methodology. Journal of Nutrition, Health and Aging, 16(4), 339-345. https://doi.org/10.1007/s12603-012-0044-x

Alzheimer's disease therapeutic trials : Eu/us task force report on recruitment, retention, and methodology. / Vellas, B.; Hampel, H.; Rouge-Bugat, M. E.; Grundman, M.; Andrieu, S.; Abu-Shakra, S.; Bateman, R.; Berman, R.; Black, R.; Carrillo, M.; Donohue, M.; Mintun, M.; Morris, J.; Petersen, Ronald Carl; Thomas, R. G.; Suhy, J.; Schneider, L.; Seely, L.; Tariot, P.; Touchon, J.; Weiner, M.; Sampaio, C.; Aisen, P.

In: Journal of Nutrition, Health and Aging, Vol. 16, No. 4, 04.2012, p. 339-345.

Research output: Contribution to journalArticle

Vellas, B, Hampel, H, Rouge-Bugat, ME, Grundman, M, Andrieu, S, Abu-Shakra, S, Bateman, R, Berman, R, Black, R, Carrillo, M, Donohue, M, Mintun, M, Morris, J, Petersen, RC, Thomas, RG, Suhy, J, Schneider, L, Seely, L, Tariot, P, Touchon, J, Weiner, M, Sampaio, C & Aisen, P 2012, 'Alzheimer's disease therapeutic trials: Eu/us task force report on recruitment, retention, and methodology', Journal of Nutrition, Health and Aging, vol. 16, no. 4, pp. 339-345. https://doi.org/10.1007/s12603-012-0044-x
Vellas, B. ; Hampel, H. ; Rouge-Bugat, M. E. ; Grundman, M. ; Andrieu, S. ; Abu-Shakra, S. ; Bateman, R. ; Berman, R. ; Black, R. ; Carrillo, M. ; Donohue, M. ; Mintun, M. ; Morris, J. ; Petersen, Ronald Carl ; Thomas, R. G. ; Suhy, J. ; Schneider, L. ; Seely, L. ; Tariot, P. ; Touchon, J. ; Weiner, M. ; Sampaio, C. ; Aisen, P. / Alzheimer's disease therapeutic trials : Eu/us task force report on recruitment, retention, and methodology. In: Journal of Nutrition, Health and Aging. 2012 ; Vol. 16, No. 4. pp. 339-345.
@article{3a24b552e1ac4520ae0e0aef10910419,
title = "Alzheimer's disease therapeutic trials: Eu/us task force report on recruitment, retention, and methodology",
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, articularly 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 drug 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.",
keywords = "Alzheimer's disease, Biomarkers, Neuroimaging",
author = "B. Vellas and H. Hampel and Rouge-Bugat, {M. E.} and M. Grundman and S. Andrieu and S. Abu-Shakra and R. Bateman and R. Berman and R. Black and M. Carrillo and M. Donohue and M. Mintun and J. Morris and Petersen, {Ronald Carl} and Thomas, {R. G.} and J. Suhy and L. Schneider and L. Seely and P. Tariot and J. Touchon and M. Weiner and C. Sampaio and P. Aisen",
year = "2012",
month = "4",
doi = "10.1007/s12603-012-0044-x",
language = "English (US)",
volume = "16",
pages = "339--345",
journal = "Journal of Nutrition, Health and Aging",
issn = "1279-7707",
publisher = "Springer Paris",
number = "4",

}

TY - JOUR

T1 - Alzheimer's disease therapeutic trials

T2 - Eu/us task force report on recruitment, retention, and methodology

AU - Vellas, B.

AU - Hampel, H.

AU - Rouge-Bugat, M. E.

AU - Grundman, M.

AU - Andrieu, S.

AU - Abu-Shakra, S.

AU - Bateman, R.

AU - Berman, R.

AU - Black, R.

AU - Carrillo, M.

AU - Donohue, M.

AU - Mintun, M.

AU - Morris, J.

AU - Petersen, Ronald Carl

AU - Thomas, R. G.

AU - Suhy, J.

AU - Schneider, L.

AU - Seely, L.

AU - Tariot, P.

AU - Touchon, J.

AU - Weiner, M.

AU - Sampaio, C.

AU - Aisen, P.

PY - 2012/4

Y1 - 2012/4

N2 - 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, articularly 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 drug 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.

AB - 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, articularly 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 drug 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.

KW - Alzheimer's disease

KW - Biomarkers

KW - Neuroimaging

UR - http://www.scopus.com/inward/record.url?scp=84863211664&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84863211664&partnerID=8YFLogxK

U2 - 10.1007/s12603-012-0044-x

DO - 10.1007/s12603-012-0044-x

M3 - Article

C2 - 22499454

AN - SCOPUS:84863211664

VL - 16

SP - 339

EP - 345

JO - Journal of Nutrition, Health and Aging

JF - Journal of Nutrition, Health and Aging

SN - 1279-7707

IS - 4

ER -