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. Heinrichs; 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

doi:10.1016/j.neurol.2013.07.017

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

Radiology

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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.

Original language	English (US)
Pages (from-to)	737-743
Number of pages	7
Journal	Revue Neurologique
Volume	169
Issue number	10
DOIs	https://doi.org/10.1016/j.neurol.2013.07.017
State	Published - 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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10.1016/j.neurol.2013.07.017

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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

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

@article{3633692ee68045aeae2c451111d5604b,

title = "Preclinical trials in autosomal dominant AD: Implementation of the DIAN-TU trial",

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.",

keywords = "Alzheimer's disease, Amyloid deposition, Amyloid-beta (Aβ), Autosomal dominant, Clinical trial",

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

note = "Funding Information: We gratefully acknowledge the Dominantly Inherited Alzheimer Network (DIAN; U19 AG032438; JC Morris, PI), the DIAN Pharma Consortium (Biogen Idec, Elan, Eli Lilly, Genentech, Hoffman La-Roche, Janssen, Mithridion, Novartis, Pfizer, Sanofi-Aventis), the Alzheimer's Association, all of the Cores of the DIAN-TU, and the participants and their families to whom we are especially indebted. The DIAN-TU is supported by funding from the Alzheimer's Association and the DIAN Pharma Consortium. ",

year = "2013",

month = oct,

doi = "10.1016/j.neurol.2013.07.017",

language = "English (US)",

volume = "169",

pages = "737--743",

journal = "Revue Neurologique",

issn = "0035-3787",

publisher = "Elsevier Masson",

number = "10",

}

TY - JOUR

T1 - Preclinical trials in autosomal dominant AD

T2 - Implementation of the DIAN-TU trial

AU - Mills, S. M.

AU - Mallmann, J.

AU - Santacruz, A. M.

AU - Fuqua, A.

AU - Carril, M.

AU - Aisen, P. S.

AU - Althage, M. C.

AU - Belyew, S.

AU - Benzinger, T. L.

AU - Brooks, W. S.

AU - Buckles, V. D.

AU - Cairns, N. J.

AU - Clifford, D.

AU - Danek, A.

AU - Fagan, A. M.

AU - Farlow, M.

AU - Fox, N.

AU - Ghetti, B.

AU - Goate, A. M.

AU - Heinrichs, D.

AU - Hornbeck, R.

AU - Jack, C.

AU - Jucker, M.

AU - Klunk, W. E.

AU - Marcus, D. S.

AU - Martins, R. N.

AU - Masters, C. M.

AU - Mayeux, R.

AU - McDade, E.

AU - Morris, J. C.

AU - Oliver, A.

AU - Ringman, J. M.

AU - Rossor, M. N.

AU - Salloway, S.

AU - Schofield, P. R.

AU - Snider, J.

AU - Snyder, P.

AU - Sperling, R. A.

AU - Stewart, C.

AU - Thomas, R. G.

AU - Xiong, C.

AU - Bateman, R. J.

N1 - Funding Information: We gratefully acknowledge the Dominantly Inherited Alzheimer Network (DIAN; U19 AG032438; JC Morris, PI), the DIAN Pharma Consortium (Biogen Idec, Elan, Eli Lilly, Genentech, Hoffman La-Roche, Janssen, Mithridion, Novartis, Pfizer, Sanofi-Aventis), the Alzheimer's Association, all of the Cores of the DIAN-TU, and the participants and their families to whom we are especially indebted. The DIAN-TU is supported by funding from the Alzheimer's Association and the DIAN Pharma Consortium.

PY - 2013/10

Y1 - 2013/10

N2 - 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.

AB - 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.

KW - Alzheimer's disease

KW - Amyloid deposition

KW - Amyloid-beta (Aβ)

KW - Autosomal dominant

KW - Clinical trial

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JO - Revue Neurologique

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ER -

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

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Keywords

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