AMYPAD Diagnostic and Patient Management Study: Rationale and design.
Alzheimers Dement
; 15(3): 388-399, 2019 03.
Article
em En
| MEDLINE
| ID: mdl-30339801
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Encéfalo
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Tomografia por Emissão de Pósitrons
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Doença de Alzheimer
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Disfunção Cognitiva
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Amiloide
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Prognostic_studies
Limite:
Aged
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Aged80
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Humans
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Middle aged
Idioma:
En
Revista:
Alzheimers Dement
Ano de publicação:
2019
Tipo de documento:
Article