Preclinical Trials In Autosomal Dominant AD: Implementation Of The DIAN-TU Trial
Authors
Sarah M. Mills
J. Mallmann
Anna M. Santacruz
A. Fuqua
M. Carril
Paul S. Aisen
M. C. Althage
S. Belyew
Tammie L. Benzinger
William S. Brooks
Virginia D. Buckles
Nigel J. Cairns
David B. Clifford
Adrian Danek
Anne M. Fagan
Martin R. Farlow
Nick C. Fox
Bernardino F. Ghetti
Alison M. Goate
D. Heinrichs
Russ C. Hornbeck
Clifford J. Jack
Mathias Jucker
William E. Klunk
Daniel S. Marcus
Ralph Martins, Edith Cowan UniversityFollow
C. M. Masters
Richard P. Mayeux
Eric M. McDade
John C. Morris
Angela Oliver
John M. Ringman
Martin N. Rossor
Stephen P. Salloway
Peter R. Schofield
Jeremy Snider
P. Snyder
Reisa A. Sperling
Christopher C. Stewart
Ronald G. Thomas
Chengjie Xiong
Randall J. Bateman
Document Type
Journal Article
Publisher
Elsevier
Faculty
Faculty of Health, Engineering and Science
School
School of Medical Sciences / Centre of Excellence for Alzheimer's Disease Research and Care
RAS ID
19799
Abstract
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.
DOI
10.1016/j.neurol.2013.07.017
Access Rights
free_to_read
Comments
Mills, S. M., Mallmann, J., Santacruz, A. M., Fuqua, A., Carril, M., Aisen, P. S., ... & Buckles, V. D. (2013). Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Revue neurologique, 169(10), 737-743. Available here