TY - JOUR
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 - 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
PY - 2019/3/1
Y1 - 2019/3/1
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.
AB - 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.
KW - Alzheimer's disease
KW - Amyloid-PET
KW - Clinical validity
KW - Cost-effectiveness
KW - Mild cognitive impairment
KW - Subjective cognitive decline
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85060337373&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30339801
U2 - https://doi.org/10.1016/j.jalz.2018.09.003
DO - https://doi.org/10.1016/j.jalz.2018.09.003
M3 - Article
C2 - 30339801
SN - 1552-5260
VL - 15
SP - 388
EP - 399
JO - Alzheimers & Dementia
JF - Alzheimers & Dementia
IS - 3
ER -