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, Martin Farlow, N. Fox, Bernardino Ghetti, A. M. Goate, D. Heinrichs & 22 others R. 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

80 Citations (Scopus)

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
Externally publishedYes

Fingerprint

Alzheimer Disease
Biomarkers
Observational Studies
Pharmaceutical Preparations
Biological Phenomena
Safety
Sexual Partners
Drug Design
Magnetic Resonance Imaging
Health
Therapeutics
Research
Population

Keywords

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Mills, S. M., Mallmann, J., Santacruz, A. M., Fuqua, A., Carril, M., Aisen, P. S., ... 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

Preclinical trials in autosomal dominant AD : Implementation of the DIAN-TU trial. / 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, Martin; Fox, N.; Ghetti, Bernardino; Goate, A. M.; Heinrichs, D.; Hornbeck, R.; Jack, C.; Jucker, M.; Klunk, W. E.; Marcus, D. S.; Martins, R. N.; Masters, C. M.; Mayeux, R.; McDade, E.; Morris, J. C.; Oliver, A.; Ringman, J. M.; Rossor, M. N.; Salloway, S.; Schofield, P. R.; Snider, J.; Snyder, P.; Sperling, R. A.; Stewart, C.; Thomas, R. G.; Xiong, C.; Bateman, R. J.

In: Revue Neurologique, Vol. 169, No. 10, 10.2013, p. 737-743.

Research output: Contribution to journalArticle

Mills, SM, Mallmann, J, Santacruz, AM, Fuqua, A, Carril, M, Aisen, PS, Althage, MC, Belyew, S, Benzinger, TL, Brooks, WS, Buckles, VD, Cairns, NJ, Clifford, D, Danek, A, Fagan, AM, Farlow, M, Fox, N, Ghetti, B, Goate, AM, Heinrichs, D, Hornbeck, R, Jack, C, Jucker, M, Klunk, WE, Marcus, DS, Martins, RN, Masters, CM, Mayeux, R, McDade, E, Morris, JC, Oliver, A, Ringman, JM, Rossor, MN, Salloway, S, Schofield, PR, Snider, J, Snyder, P, Sperling, RA, Stewart, C, Thomas, RG, Xiong, C & Bateman, RJ 2013, 'Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial', Revue Neurologique, vol. 169, no. 10, pp. 737-743. https://doi.org/10.1016/j.neurol.2013.07.017
Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS et al. Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial. Revue Neurologique. 2013 Oct;169(10):737-743. https://doi.org/10.1016/j.neurol.2013.07.017
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, Martin ; Fox, N. ; Ghetti, Bernardino ; Goate, A. M. ; Heinrichs, D. ; Hornbeck, R. ; Jack, C. ; Jucker, M. ; Klunk, W. E. ; Marcus, D. S. ; Martins, R. N. ; Masters, C. M. ; Mayeux, R. ; McDade, E. ; Morris, J. C. ; Oliver, A. ; Ringman, J. M. ; Rossor, M. N. ; Salloway, S. ; Schofield, P. R. ; Snider, J. ; Snyder, P. ; Sperling, R. A. ; Stewart, C. ; Thomas, R. G. ; Xiong, C. ; Bateman, R. J. / Preclinical trials in autosomal dominant AD : Implementation of the DIAN-TU trial. In: Revue Neurologique. 2013 ; Vol. 169, No. 10. pp. 737-743.
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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.",
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AU - Althage, M. C.

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AU - Heinrichs, D.

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