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; Philip Scheltens; Mark E Schmidt; Jonathan Schott; Andrew Stephens; Bart van Berckel; Bruno Vellas; Zuzana Walker; Nicola Raffa

doi:10.1016/j.jalz.2018.09.003

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 SavichevaPhilip Scheltens, Mark E Schmidt, Jonathan Schott, Andrew Stephens, Bart van Berckel, Bruno Vellas, Zuzana Walker, Nicola Raffa

Centro San Giovanni di Dio - Fatebenefratelli

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Journal	Alzheimer's and Dementia
DOIs	https://doi.org/10.1016/j.jalz.2018.09.003
Publication status	E-pub ahead of print - Oct 16 2018

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10.1016/j.jalz.2018.09.003

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Frisoni, G. B., 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., Alves, I. L., Molinuevo, J-L., Nordberg, A., Payoux, P., Ritchie, C., ... Raffa, N. (2018). AMYPAD Diagnostic and Patient Management Study: Rationale and design. Alzheimer's and Dementia. 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; Alves, Isadora Lopes; 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: Alzheimer's and Dementia, 16.10.2018.

Research output: Contribution to journal › Article › peer-review

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, Alves, IL, 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 2018, 'AMYPAD Diagnostic and Patient Management Study: Rationale and design', Alzheimer's and Dementia. https://doi.org/10.1016/j.jalz.2018.09.003

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 ; Alves, Isadora Lopes ; 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: Alzheimer's and Dementia. 2018.

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title = "AMYPAD Diagnostic and Patient Management Study: Rationale and design",

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.",

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 Alves, {Isadora Lopes} 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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doi = "10.1016/j.jalz.2018.09.003",

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T1 - AMYPAD Diagnostic and Patient Management Study

T2 - Rationale and design

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 - Alves, Isadora Lopes

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

PY - 2018/10/16

Y1 - 2018/10/16

N2 - 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.

AB - 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.

U2 - 10.1016/j.jalz.2018.09.003

DO - 10.1016/j.jalz.2018.09.003

M3 - Article

C2 - 30339801

JO - Alzheimer's and Dementia

JF - Alzheimer's and Dementia

SN - 1552-5260

ER -

AMYPAD Diagnostic and Patient Management Study: Rationale and design

Abstract

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