AMYPAD Diagnostic and Patient Management Study: Rationale and design

Giovanni B. Frisoni, Frederik Barkhof, Daniele Altomare, Johannes Berkhof, Marina Boccardi, Elisa Canzoneri, Lyduine Collij, Alexander Drzezga, Gill Farrar, Valentina Garibotto, Rossella Gismondi, Juan-Domingo Gispert, Frank Jessen, Miia Kivipelto, Isadora Lopes Alves, José-Luis Molinuevo, Agneta Nordberg, Pierre Payoux, Craig Ritchie, Irina Savicheva & 8 others Philip Scheltens, Mark E. Schmidt, Jonathan Schott, Andrew Stephens, Bart van Berckel, Bruno Vellas, Zuzana Walker, Nicola Raffa

Research output: Contribution to journalArticleAcademicpeer-review

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.
LanguageEnglish
Pages388-399
JournalAlzheimers & Dementia
Volume15
Issue number3
DOIs
Publication statusPublished - Mar 2019

Cite this

Frisoni, Giovanni B. ; Barkhof, Frederik ; Altomare, Daniele ; Berkhof, Johannes ; Boccardi, Marina ; Canzoneri, Elisa ; Collij, Lyduine ; Drzezga, Alexander ; Farrar, Gill ; Garibotto, Valentina ; Gismondi, Rossella ; Gispert, Juan-Domingo ; Jessen, Frank ; Kivipelto, Miia ; Lopes Alves, Isadora ; Molinuevo, José-Luis ; Nordberg, Agneta ; Payoux, Pierre ; Ritchie, Craig ; Savicheva, Irina ; Scheltens, Philip ; Schmidt, Mark E. ; Schott, Jonathan ; Stephens, Andrew ; van Berckel, Bart ; Vellas, Bruno ; Walker, Zuzana ; Raffa, Nicola. / AMYPAD Diagnostic and Patient Management Study : Rationale and design. In: Alzheimers & Dementia. 2019 ; Vol. 15, No. 3. pp. 388-399.
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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.",
author = "Frisoni, {Giovanni B.} and Frederik Barkhof and Daniele Altomare and Johannes Berkhof and Marina Boccardi and Elisa Canzoneri and Lyduine Collij and Alexander Drzezga and Gill Farrar and Valentina Garibotto and Rossella Gismondi and Juan-Domingo Gispert and Frank Jessen and Miia Kivipelto and {Lopes Alves}, Isadora and Jos{\'e}-Luis Molinuevo and Agneta Nordberg and Pierre Payoux and Craig Ritchie and Irina Savicheva and Philip Scheltens and Schmidt, {Mark E.} and Jonathan Schott and Andrew Stephens and {van Berckel}, Bart and Bruno Vellas and Zuzana Walker and Nicola Raffa",
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Frisoni, GB, Barkhof, F, Altomare, D, Berkhof, J, Boccardi, M, Canzoneri, E, Collij, L, Drzezga, A, Farrar, G, Garibotto, V, Gismondi, R, Gispert, J-D, Jessen, F, Kivipelto, M, Lopes Alves, I, Molinuevo, J-L, Nordberg, A, Payoux, P, Ritchie, C, Savicheva, I, Scheltens, P, Schmidt, ME, Schott, J, Stephens, A, van Berckel, B, Vellas, B, Walker, Z & Raffa, N 2019, 'AMYPAD Diagnostic and Patient Management Study: Rationale and design', Alzheimers & Dementia, vol. 15, no. 3, pp. 388-399. https://doi.org/10.1016/j.jalz.2018.09.003, https://doi.org/10.1016/j.jalz.2018.09.003

AMYPAD Diagnostic and Patient Management Study : Rationale and design. / Frisoni, Giovanni B.; Barkhof, Frederik; Altomare, Daniele; Berkhof, Johannes; Boccardi, Marina; Canzoneri, Elisa; Collij, Lyduine; Drzezga, Alexander; Farrar, Gill; Garibotto, Valentina; Gismondi, Rossella; Gispert, Juan-Domingo; Jessen, Frank; Kivipelto, Miia; Lopes Alves, Isadora; Molinuevo, José-Luis; Nordberg, Agneta; Payoux, Pierre; Ritchie, Craig; Savicheva, Irina; Scheltens, Philip; Schmidt, Mark E.; Schott, Jonathan; Stephens, Andrew; van Berckel, Bart; Vellas, Bruno; Walker, Zuzana; Raffa, Nicola.

In: Alzheimers & Dementia, Vol. 15, No. 3, 03.2019, p. 388-399.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - AMYPAD Diagnostic and Patient Management Study

T2 - Alzheimers & Dementia

AU - Frisoni, Giovanni B.

AU - Barkhof, Frederik

AU - Altomare, Daniele

AU - Berkhof, Johannes

AU - Boccardi, Marina

AU - Canzoneri, Elisa

AU - Collij, Lyduine

AU - Drzezga, Alexander

AU - Farrar, Gill

AU - Garibotto, Valentina

AU - Gismondi, Rossella

AU - Gispert, Juan-Domingo

AU - Jessen, Frank

AU - Kivipelto, Miia

AU - Lopes Alves, Isadora

AU - Molinuevo, José-Luis

AU - Nordberg, Agneta

AU - Payoux, Pierre

AU - Ritchie, Craig

AU - Savicheva, Irina

AU - Scheltens, Philip

AU - Schmidt, Mark E.

AU - Schott, Jonathan

AU - Stephens, Andrew

AU - van Berckel, Bart

AU - Vellas, Bruno

AU - Walker, Zuzana

AU - Raffa, Nicola

N1 - Copyright © 2018. Published by Elsevier Inc.

PY - 2019/3

Y1 - 2019/3

N2 - 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.

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