Journal
REVUE NEUROLOGIQUE
Volume 169, Issue 10, Pages 737-743Publisher
MASSON EDITEUR
DOI: 10.1016/j.neurol.2013.07.017
Keywords
Alzheimer's disease; Amyloid-beta (A beta); Autosomal dominant; Amyloid deposition; Clinical trial
Categories
Funding
- Alzheimer's Association
- DIAN Pharma Consortium
- National Institute for Health Research [NF-SI-0508-10123, NF-SI-0512-10033] Funding Source: researchfish
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The Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU) was formed to direct the design and management of interventional therapeutic trials of international DIAN and autosomal dominant Alzheimer's disease (ADAD) participants. The goal of the DIAN-TU is to implement safe trials that have the highest likelihood of success while advancing scientific understanding of these diseases and clinical effects of proposed therapies. The DIAN-TU has launched a trial design that leverages the existing infrastructure of the ongoing DIAN observational study, takes advantage of a variety of drug targets, incorporates the latest results of biomarker and cognitive data collected during the observational study, and implements biomarkers measuring Alzheimer's disease (AD) biological processes to improve the efficiency of trial design. The DIAN-TU trial design is unique due to the sophisticated design of multiple drugs, multiple pharmaceutical partners, academics servings as sponsor, geographic distribution of a rare population and intensive safety and biomarker assessments. The implementation of the operational aspects such as home health research delivery, safety magnetic resonance imagings (MRIs) at remote locations, monitoring clinical and cognitive measures, and regulatory management involving multiple pharmaceutical sponsors of the complex DIAN-TU trial are described. Published by Elsevier Masson SAS.
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