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.
authors.affiliation: DIAN-TU, Washington University, 660, S. Euclid Avenue, Campus Box 8111, St. Louis, MO 63108, USA.
authors.forename: S M
authors.initials: SM
authors.lastname: Mills
authors.forename: J
authors.initials: J
authors.lastname: Mallmann
authors.forename: A M
authors.initials: AM
authors.lastname: Santacruz
authors.forename: A
authors.initials: A
authors.lastname: Fuqua
authors.forename: M
authors.initials: M
authors.lastname: Carril
authors.forename: P S
authors.initials: PS
authors.lastname: Aisen
authors.forename: M C
authors.initials: MC
authors.lastname: Althage
authors.forename: S
authors.initials: S
authors.lastname: Belyew
authors.forename: T L
authors.initials: TL
authors.lastname: Benzinger
authors.forename: W S
authors.initials: WS
authors.lastname: Brooks
authors.forename: V D
authors.initials: VD
authors.lastname: Buckles
authors.forename: N J
authors.initials: NJ
authors.lastname: Cairns
authors.forename: D
authors.initials: D
authors.lastname: Clifford
authors.forename: A
authors.initials: A
authors.lastname: Danek
authors.forename: A M
authors.initials: AM
authors.lastname: Fagan
authors.forename: M
authors.initials: M
authors.lastname: Farlow
authors.forename: N
authors.initials: N
authors.lastname: Fox
authors.forename: B
authors.initials: B
authors.lastname: Ghetti
authors.forename: A M
authors.initials: AM
authors.lastname: Goate
authors.forename: D
authors.initials: D
authors.lastname: Heinrichs
authors.forename: R
authors.initials: R
authors.lastname: Hornbeck
authors.forename: C
authors.initials: C
authors.lastname: Jack
authors.forename: M
authors.initials: M
authors.lastname: Jucker
authors.forename: W E
authors.initials: WE
authors.lastname: Klunk
authors.forename: D S
authors.initials: DS
authors.lastname: Marcus
authors.forename: R N
authors.initials: RN
authors.lastname: Martins
authors.forename: C M
authors.initials: CM
authors.lastname: Masters
authors.forename: R
authors.initials: R
authors.lastname: Mayeux
authors.forename: E
authors.initials: E
authors.lastname: McDade
authors.forename: J C
authors.initials: JC
authors.lastname: Morris
authors.forename: A
authors.initials: A
authors.lastname: Oliver
authors.forename: J M
authors.initials: JM
authors.lastname: Ringman
authors.forename: M N
authors.initials: MN
authors.lastname: Rossor
authors.forename: S
authors.initials: S
authors.lastname: Salloway
authors.forename: P R
authors.initials: PR
authors.lastname: Schofield
authors.forename: J
authors.initials: J
authors.lastname: Snider
authors.forename: P
authors.initials: P
authors.lastname: Snyder
authors.forename: R A
authors.initials: RA
authors.lastname: Sperling
authors.forename: C
authors.initials: C
authors.lastname: Stewart
authors.forename: R G
authors.initials: RG
authors.lastname: Thomas
authors.forename: C
authors.initials: C
authors.lastname: Xiong
authors.forename: R J
authors.initials: RJ
authors.lastname: Bateman
mesh_terms: D000544:Alzheimer Disease / Q000235:genetics* / Q000628:therapy*; D035843:Biomedical Research / Q000379:methods*; D002986:Clinical Trials as Topic / Q000379:methods*; D005799:Genes, Dominant; D006699:Home Care Services; D006801:Humans; D008279:Magnetic Resonance Imaging; D008510:Medication Systems, Hospital; D008991:Monitoring, Physiologic / Q000379:methods; D018579:Patient Selection; D012107:Research Design
keywords: Alzheimer's disease; Amyloid deposition; Amyloid-beta (Aβ); Autosomal dominant; Autosomique dominante; Bêta-amyloïde; Clinical trial; Dépôt de substance amyloïde; Essai clinique; Maladie d’Alzheimer
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