CoChat
Sign Up
Cited by 147Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchStatistical Methods in Clinical Trials

The DOI matches its Crossref record; 20 of the 21 references it cites were found in a registry or an index.

Designing drug trials for Alzheimer's disease: What we have learned from the release of the phase III antibody trials: A report from the EU/US/CTAD Task Force

Vellas, Bruno, Carrillo, Maria C., Sampaio, Cristina, Brashear, H. Robert, Siemers, Eric, Hampel, Harald, Schneider, Lon S., Weiner, Michael, Doody, Rachelle, Khachaturian, Zaven, Cedarbaum, Jesse, Grundman, Michael, Broich, Karl, Giacobini, Ezio, Dubois, Bruno, Sperling, Reisa, Wilcock, Gordon K., Fox, Nick, Scheltens, Philip, Touchon, Jacques, Hendrix, Suzanne, Andrieu, Sandrine, Aisen, Paul, EU/US/CTAD Task Force Members·2013·Alzheimer's & Dementia
DOI 10.1016/j.jalz.2013.03.007
Open this paper in CoChat — free account

Abstract

An international task force of investigators from academia, industry, nonprofit foundations, and regulatory agencies met in Monte Carlo, Monaco, on October 31, 2012, to review lessons learned from the recent bapineuzumab and solanezumab trials, and to incorporate insights gained from these trials into future clinical studies. Although there is broad consensus that Alzheimer's disease (AD) should be treated during its earliest stages, the concept of secondary prevention has evolved to be described more accurately as treatment of preclinical, presymptomatic, or early AD. There continues to be a strong emphasis on biomarkers and a need for new biomarkers; however, there has also been a realization, based on completed trials, that the most reliable indicator of clinical efficacy across the entire spectrum of disease from asymptomatic to AD dementia is likely a measure of cognition. The task force made many recommendations that should improve the likelihood of success in future trials, including larger phase 2 or combined phase 2/phase 3 studies, clear evidence of target engagement in the central nervous system, evidence of downstream effects on biomarkers before initiating phase 3 studies, consideration of adaptive and targeted trial designs, and use of sensitive measures of cognition as the most robust indicator of treatment benefit.

Overview

Integrity signals

Registry

Crossref · 10.1016/j.jalz.2013.03.007

Cites

20 of 20 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Research works printed but not linked: 1

  1. Tosun D, 2012, Paper presented at: Alzheimer's Association International Conference,

Cited by

Sorted by citations

See all 147

Related

See all

Metadata

Authors
Vellas, B., Carrillo, M. C., Sampaio, C., Brashear, H. R., Siemers, E., Hampel, H., Schneider, L. S., Weiner, M., Doody, R., Khachaturian, Z., Cedarbaum, J., Grundman, M., Broich, K., Giacobini, E., Dubois, B., Sperling, R., Wilcock, G. K., Fox, N., Scheltens, P., Touchon, J., Hendrix, S., Andrieu, S., Aisen, P., & EU/US/CTAD Task Force Members
Affiliations
  • Université Toulouse III - Paul Sabatier (FR)
  • Alzheimer's Association Chicago IL USA
  • CHDI Foundation (US)
  • Janssen (United States) (US)
  • Eli Lilly (United States) (US)
  • Goethe University Frankfurt (DE)
  • University of Southern California (US)
  • San Francisco VA Medical Center (US)
  • Baylor College of Medicine (US)
  • The Campaign to Prevent Alzheimer's Disease by 2020 Potomac MD USA
  • Bristol-Myers Squibb (United States) (US)
  • Global R&D Partners, LLC San Diego CA USA
  • Federal Institute for Drugs and Medical Devices (DE)
  • University of Geneva (CH)
  • Pitié-Salpêtrière Hospital (FR)
  • Brigham and Women's Hospital (US)
  • University of Oxford (GB)
  • UCL Queen Square Institute of Neurology (GB)
  • Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
  • Centre Hospitalier Universitaire de Montpellier (FR)
  • Pentara Corporation Salt Lake City UT USA
  • University of California San Diego (US)
Corresponding author
Vellas, Bruno
ORCID
Venue
Alzheimer's & Dementia
Publisher
Wiley
Published
2013-07
Volume
9
Issue
4
Pages
438-444
ISSN
  • 1552-5260 (ISSN-L)
  • 1552-5279
DOI
10.1016/j.jalz.2013.03.007
OpenAlex
W2061602279
Cited by
147
References
21
Citations by year
2026: 1 · 2025: 3 · 2024: 4 · 2023: 3 · 2022: 4 · 2021: 3 · 2020: 6 · 2019: 8 · 2018: 15 · 2017: 10 · 2016: 30 · 2015: 25 · 2014: 20 · 2013: 15
FWCI
20.83
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Alzheimer s & Dementia (publishedVersion)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (publishedVersion)
  • Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
Funders
Katharina-Hardt-Foundation, Bad Homburg, Germany
Topics
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
Alzheimer's disease
MeSH terms
Aged, Aged, 80 and over, Alzheimer Disease, Apolipoproteins E, Atrophy, Brain, Brain Chemistry, Brain Edema, Humans, Multicenter Studies as Topic, Biomarkers, Randomized Controlled Trials as Topic, Amyloid beta-Peptides, Treatment Failure, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Disease Progression, Patient Selection, Nootropic Agents, Endpoint Determination, Neuroimaging, Cognitive Dysfunction, Antibodies, Monoclonal, Humanized

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review