Biomarkers for Alzheimer's disease therapeutic trials
Autor: | Harald, Hampel, Gordon, Wilcock, Sandrine, Andrieu, Paul, Aisen, Kaj, Blennow, K, Broich, Maria, Carrillo, Nick C, Fox, Giovanni B, Frisoni, Maria, Isaac, Simon, Lovestone, Agneta, Nordberg, David, Prvulovic, Christina, Sampaio, Philip, Scheltens, Michael, Weiner, Bengt, Winblad, Nicola, Coley, Bruno, Vellas, M, Zvartau-Hind |
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Přispěvatelé: | Repositório da Universidade de Lisboa, Neurology, NCA - Neurodegeneration |
Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
Brain Mapping
Clinical Trials as Topic General Neuroscience Placebo-controlled study Brain Neuroimaging Neuropathology Disease medicine.disease Early diagnosis Clinical trial Drug development Alzheimer Disease Inclusion and exclusion criteria medicine Humans Alzheimer's disease Radionuclide Imaging Psychology Adverse effect Neuroscience Alzheimer’s disease Biomarkers Antipsychotic Agents |
Zdroj: | Progress in Neurobiology, 95(4), 579-593. Elsevier Limited Hampel, H, Wilcock, G, Andrieu, S, Aisen, P, Blennow, K, Broich, K, Carrillo, M, Fox, N C, Frisoni, G B, Isaac, M, Lovestone, S, Nordberg, A, Prvulovic, D, Sampaio, C, Scheltens, P, Weiner, M, Winblad, B, Coley, N & Vellas, B 2011, ' Biomarkers for Alzheimer's disease therapeutic trials ', Progress in Neurobiology, vol. 95, no. 4, pp. 579-593 . https://doi.org/10.1016/j.pneurobio.2010.11.005 Repositório Científico de Acesso Aberto de Portugal Repositório Científico de Acesso Aberto de Portugal (RCAAP) instacron:RCAAP |
ISSN: | 0301-0082 |
Popis: | © 2010 Elsevier Ltd. All rights reserved The development of disease-modifying treatments for Alzheimer's disease requires innovative trials with large numbers of subjects and long observation periods. The use of blood, cerebrospinal fluid or neuroimaging biomarkers is critical for the demonstration of disease-modifying therapy effects on the brain. Suitable biomarkers are those which reflect the progression of AD related molecular mechanisms and neuropathology, including amyloidogenic processing and aggregation, hyperphosphorylation, accumulation of tau and neurofibrillary tangles, progressive functional, metabolic and structural decline, leading to neurodegeneration, loss of brain tissue and cognitive symptoms. Biomarkers should be used throughout clinical trial phases I–III of AD drug development. They can be used to enhance inclusion and exclusion criteria, or as baseline predictors to increase the statistical power of trials. Validated and qualified biomarkers may be used as outcome measures to detect treatment effects in pivotal clinical trials. Finally, biomarkers can be used to identify adverse effects. Questions regarding which biomarkers should be used in clinical trials, and how, are currently far from resolved. The Oxford Task Force continues and expands the work of our previous international expert task forces on disease-modifying trials and on endpoints for Alzheimer's disease clinical trials. The aim of this initiative was to bring together a selected number of key international opinion leaders and experts from academia, regulatory agencies and industry to condense the current knowledge and state of the art regarding the best use of biological markers in Alzheimer's disease therapy trials and to propose practical recommendations for the planning of future AD trials. GW was partly funded by the NIHR Biomedical Research Center Programme, Oxford, UK. |
Databáze: | OpenAIRE |
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