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

Research output: Contribution to journalArticle

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 languageEnglish
JournalAlzheimer's and Dementia
DOIs
Publication statusE-pub ahead of print - Oct 16 2018

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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