Evidence map›Paper›PMID 22499454›Full record

ArticleThe journal of nutrition, health & aging2012

Alzheimer's disease therapeutic trials: EU/US Task Force report on recruitment, retention, and methodology.

B Vellas, H Hampel, M E Rougé-Bugat, M Grundman, S Andrieu, S Abu-Shakra, R Bateman, R Berman, R Black, M Carrillo and 14 more

Open access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The journal of nutrition, health & aging, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
14.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Motivators for Alzheimer's disease clinical trial participation.Aging clinical and experimental research · 2018
    Article
  11. Article
  12. Review
  13. The Alzheimer's Disease Neuroimaging Initiative 3: Continued innovation for clinical trial improvement.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2017
    Review
  14. Article
  15. Preclinical Alzheimer's disease: Definition, natural history, and diagnostic criteria.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2016
    Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 16 institutions in 3 countries.

B VellasInserm, U558, Toulouse, France.
H Hampel
M E Rougé-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
University of California San Diego · USUniversité Fédérale de Toulouse Midi-Pyrénées · FRAlzheimer's Association · USBanner Alzheimer’s InstituteBristol-Myers Squibb (United States) · USCentre Hospitalier Universitaire de Montpellier · FRCHDI Foundation · USGoethe University Frankfurt · DEInserm · FRMayo Clinic in Arizona · USMedication Management (United States) · USPfizer (United States) · USscPharmaceuticals (United States) · USSunesis (United States) · USUniversity of California, San Francisco · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 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.

Indexed as

Clinical Trials as TopicPatient SelectionAlzheimer DiseaseBiomarkersDisease ProgressionEuropean UnionFollow-Up StudiesHumansInternational CooperationJapanMulticenter Studies as TopicNeuroimagingSurveys and QuestionnairesUnited StatesBiomarkers

Identifiers

PMID22499454
PMCPMC12878019
OpenAlexW2004665143

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.