Premium
AMYPAD Diagnostic and Patient Management Study: Rationale and design
Author(s) -
Frisoni Giovanni B.,
Barkhof Frederik,
Altomare Daniele,
Berkhof Johannes,
Boccardi Marina,
Canzoneri Elisa,
Collij Lyduine,
Drzezga Alexander,
Farrar Gill,
Garibotto Valentina,
Gismondi Rossella,
Gispert JuanDomingo,
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 M.,
Stephens Andrew,
Berckel Bart,
Vellas Bruno,
Walker Zuzana,
Raffa Nicola
Publication year - 2019
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2018.09.003
Subject(s) - medicine , dementia , reimbursement , positron emission tomography , clinical endpoint , randomized controlled trial , neuroimaging , disease , intensive care medicine , alzheimer's disease , health care , radiology , psychiatry , economics , economic growth
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.