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AMYPAD Diagnostic and Patient Management Study: Rationale and Design

Frisoni, GB; Barkhof, F; Altomare, D; Berkhof, J; Boccardi, M; Canzoneri, E; Collij, L; ... Raffa, N; + view all (2019) AMYPAD Diagnostic and Patient Management Study: Rationale and Design. Alzheimer's & Dementia , 15 (3) pp. 388-399. 10.1016/j.jalz.2018.09.003. Green open access

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Abstract

INTRODUCTION: Reimbursement of amyloid-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.

Type: Article
Title: AMYPAD Diagnostic and Patient Management Study: Rationale and Design
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.jalz.2018.09.003
Publisher version: https://doi.org/10.1016/j.jalz.2018.09.003
Language: English
Additional information: Copyright © 2018 The Authors. Published by Elsevier Inc. on behalf of the Alzheimer’s Association. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: Alzheimer's disease, Amyloid-PET, Clinical validity, Cost-effectiveness, Mild cognitive impairment, Subjective cognitive decline
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Brain Repair and Rehabilitation
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Neurodegenerative Diseases
URI: https://discovery.ucl.ac.uk/id/eprint/10060078
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