Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial

S. M. Mills, J. Mallmann, A. M. Santacruz, A. Fuqua, M. Carril, P. S. Aisen, M. C. Althage, S. Belyew, T. L. Benzinger, W. S. Brooks, V. D. Buckles, N. J. Cairns, D. Clifford, A. Danek, A. M. Fagan, M. Farlow, N. Fox, B. Ghetti, A. M. Goate, D. HeinrichsR. Hornbeck, C. Jack, M. Jucker, W. E. Klunk, D. S. Marcus, R. N. Martins, C. M. Masters, R. Mayeux, E. McDade, J. C. Morris, A. Oliver, J. M. Ringman, M. N. Rossor, S. Salloway, P. R. Schofield, J. Snider, P. Snyder, R. A. Sperling, C. Stewart, R. G. Thomas, C. Xiong, R. J. Bateman

Research output: Contribution to journalArticle

90 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)737-743
Number of pages7
JournalRevue Neurologique
Volume169
Issue number10
DOIs
StatePublished - Oct 2013

Keywords

  • Alzheimer's disease
  • Amyloid deposition
  • Amyloid-beta (Aβ)
  • Autosomal dominant
  • Clinical trial

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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    Mills, S. M., Mallmann, J., Santacruz, A. M., Fuqua, A., Carril, M., Aisen, P. S., Althage, M. C., Belyew, S., Benzinger, T. L., Brooks, W. S., Buckles, V. D., Cairns, N. J., Clifford, D., Danek, A., Fagan, A. M., Farlow, M., Fox, N., Ghetti, B., Goate, A. M., ... Bateman, R. J. (2013). Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial. Revue Neurologique, 169(10), 737-743. https://doi.org/10.1016/j.neurol.2013.07.017