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

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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

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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.

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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: Vellas, Bruno
Sampaio, Cristina
Siemers, Eric
Hampel, Harald
Schneider, Lon S.
Weiner, Michael
Cedarbaum, Jesse
Broich, Karl
Dubois, Bruno
Sperling, Reisa
Wilcock, Gordon K.
Fox, Nick
Scheltens, Philip
Hendrix, Suzanne
Andrieu, Sandrine
Aisen, Paul
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

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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

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