Frisoni, Giovanni B., Barkhof, Frederik ORCID: 0000-0003-3543-3706, Altomare, Daniele ORCID: 0000-0003-1905-8993, Berkhof, Johannes, Boccardi, Marina ORCID: 0000-0001-6744-8246, Canzoneri, Elisa, Collij, Lyduine, Drzezga, Alexander, Farrar, Gill, Garibotto, Valentina ORCID: 0000-0003-2422-698X, Gismondi, Rossella, Gispert, Juan-Domingo, Jessen, Frank, Kivipelto, Miia, Alves, Isadora Lopes, Luis Molinuevo, Jose, Nordberg, Agneta ORCID: 0000-0001-7345-5151, Payoux, Pierre ORCID: 0000-0002-1374-1620, Ritchie, Craig, Savicheva, Irina, Scheltens, Philip ORCID: 0000-0002-1046-6408, Schmidt, Mark E., Schott, Jonathan M., Stephens, Andrew, van Berckel, Bart, Vellas, Bruno, Walker, Zuzana and Raffa, Nicola (2019). AMYPAD Diagnostic and Patient Management Study: Rationale and design. Alzheimers. Dement., 15 (3). S. 388 - 400. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1552-5279

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Abstract

Introduction: Reimbursement of amyloid-positron emission tomography (PET) is lagging due to the lack of definitive evidence on its clinical utility and cost-effectiveness. The Amyloid Imaging to Prevent Alzheimer's Disease-Diagnostic and Patient Management Study (AMYPAD-DPMS) is designed to fill this gap. Methods: AMYPAD-DPMS is a phase 4, multicenter, prospective, randomized controlled study. Nine hundred patients with subjective cognitive decline plus, mild cognitive impairment, and dementia possibly due to Alzheimer's disease will be randomized to ARM1, amyloid-PET performed early in the diagnostic workup; ARM2, amyloid-PET performed after 8 months; and ARM3, amyloid-PET performed whenever the physician chooses to do so. Endpoints: The primary endpoint is the difference between ARM1 and ARM2 in the proportion of patients receiving a very-high-confidence etiologic diagnosis after 3 months. Secondary endpoints address diagnosis and diagnostic confidence, diagnostic/therapeutic management, health economics and patient-related outcomes, and methods for image quantitation. Expected Impacts: AMYPAD-DPMS will supply physicians and health care payers with real-world data to plan management decisions. (C) 2018 The Authors. Published byElsevier Inc.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Frisoni, Giovanni B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Barkhof, FrederikUNSPECIFIEDorcid.org/0000-0003-3543-3706UNSPECIFIED
Altomare, DanieleUNSPECIFIEDorcid.org/0000-0003-1905-8993UNSPECIFIED
Berkhof, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boccardi, MarinaUNSPECIFIEDorcid.org/0000-0001-6744-8246UNSPECIFIED
Canzoneri, ElisaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Collij, LyduineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Drzezga, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Farrar, GillUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Garibotto, ValentinaUNSPECIFIEDorcid.org/0000-0003-2422-698XUNSPECIFIED
Gismondi, RossellaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gispert, Juan-DomingoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jessen, FrankUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kivipelto, MiiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alves, Isadora LopesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luis Molinuevo, JoseUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nordberg, AgnetaUNSPECIFIEDorcid.org/0000-0001-7345-5151UNSPECIFIED
Payoux, PierreUNSPECIFIEDorcid.org/0000-0002-1374-1620UNSPECIFIED
Ritchie, CraigUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Savicheva, IrinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scheltens, PhilipUNSPECIFIEDorcid.org/0000-0002-1046-6408UNSPECIFIED
Schmidt, Mark E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schott, Jonathan M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stephens, AndrewUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
van Berckel, BartUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vellas, BrunoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Walker, ZuzanaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Raffa, NicolaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-155645
DOI: 10.1016/j.jalz.2018.09.003
Journal or Publication Title: Alzheimers. Dement.
Volume: 15
Number: 3
Page Range: S. 388 - 400
Date: 2019
Publisher: ELSEVIER SCIENCE INC
Place of Publication: NEW YORK
ISSN: 1552-5279
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
ALZHEIMERS ASSOCIATION WORKGROUPS; POSITRON-EMISSION-TOMOGRAPHY; MILD COGNITIVE IMPAIRMENT; AMYLOID-BETA PLAQUES; NATIONAL INSTITUTE; CLINICAL VALIDITY; WORK-UP; PET; DEMENTIA; DISEASEMultiple languages
Clinical NeurologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/15564

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