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*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

106 Citations (Scopus)


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
Pages (from-to)737-743
Number of pages7
JournalRevue Neurologique
Issue number10
Publication statusPublished - Oct 2013
Externally publishedYes

Bibliographical note

Erratum can be found in Revue Neurologique volume 169(12), p1018,


  • Alzheimer's disease
  • amyloid deposition
  • amyloid-beta (Aβ)
  • autosomal dominant
  • clinical trial


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