E.U./U.S. CTAD TASK FORCE ON ALZHEIMER\'S TRIAL POPULATIONS
Abstract
Successful therapeutic trials require well-targeted populations to demonstrate the effectiveness of a drug candidate. Most trials in the field of Alzheimer's disease (AD) have been conducted in patients with mild to moderate dementia. However, the advent of amyloid PET imaging has demonstrated that a significant proportion of individuals enrolled in such studies do not have evidence of brain amyloidosis and may in fact not have Alzheimer's disease. Further, dementia represents an advanced stage of neurodegeneration, perhaps too late for significant benefits of disease-modifying interventions. The successful development of effective disease-slowing therapies requires a study population selected in accordance with the mechanism of the specific intervention. An international task force of investigators from academia, industry, non-profit foundations, and regulatory agencies met in San Diego, California, USA, on November 13, 2013, to address issues related to screening and identification of clinical trial participants, and the ramifications of decisions made in this regard for drug development in AD and other dementias.
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Successful translation from neurodegenerative animal models to human clinical trials is far from adequate.
“successful translation from neurodegenerative animal models to human clinical trials is far from adequate”
From Cross-Species Single-Cell Analysis Reveals Divergence of the Primate Microglia Program (2019) · cites this paper as Vellas et al., 2014
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Cross-Species Single-Cell Analysis Reveals Divergence of the Primate Microglia Program
Geirsdottir, L., David, E., Keren-Shaul, H., Weiner, A., Bohlen, S. C., Neuber, J., Balic, A., Giladi, A., Sheban, F., Dutertre, C.-A., et al. (2019) · Cell · doi:10.1016/j.cell.2019.11.010 · Cited by 461 · see citing works
- Authors
- Vellas, B., Sampaio, C., Bateman, R., Boxer, A., Carrillo, M. C., Cummings, J., Dubois, B., Hampel, H., Katz, R., Khachaturian, Z., Gauthier, S., Johnson, K., Karlawish, J., Mintun, M., Petersen, R., Rafii, M., Robert, P., Schneider, L. S., Siemers, E., Sperling, R., Tariot, P., Touchon, J., Weiner, M., Andrieu, S., & Aisen, P.
- Affiliations
- Inserm (FR)
- ORCID
- Venue
- The Journal of Prevention of Alzheimer's Disease
- Publisher
- Elsevier BV
- Published
- 2014
- Volume
- 1
- Issue
- 2
- Pages
- 1-7
- ISSN
- 2274-5807 (ISSN-L)
- OpenAlex
- W2566310046
- Cited by
- 5
- References
- 0
- Citations by year
- 2019: 2 · 2015: 1 · 2014: 2
- FWCI
- 0.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Prevention of Alzheimer s Disease (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Keywords
- Alzheimer's disease, clinical trial populations, amyloid PET, cerebral amyloidosis, dementia, disease-modifying therapy, drug development, mild cognitive impairment
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