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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
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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“Trials featuring intravenous infusions of antibodies to Aβ failed to meet their primary endpoints [252].”
From The Alzheimer’s disease mitochondrial cascade hypothesis: progress and perspectives (2014) · cites this paper as [252]
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“despite the fact these approaches appear to accelerate, not impact, or at best very minimally slow symptomatic subject progression.”
From The Alzheimer’s disease mitochondrial cascade hypothesis: progress and perspectives (2014) · cites this paper as [252]
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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
- 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
- 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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