AMYPAD Diagnostic and Patient Management Study: Rationale and design.

Aged Aged, 80 and over Alzheimer Disease / diagnostic imaging Amyloid / metabolism Brain / diagnostic imaging Clinical Trial Protocols as Topic Clinical Trials, Phase IV as Topic Cognitive Dysfunction / diagnostic imaging Cost-Benefit Analysis Disease Management Humans Middle Aged Multicenter Studies as Topic Positron-Emission Tomography / economics Randomized Controlled Trials as Topic Time Factors

Alzheimer's disease Amyloid-PET Clinical validity Cost-effectiveness Mild cognitive impairment Subjective cognitive decline

Journal

Alzheimer's & dementia : the journal of the Alzheimer's Association

ISSN: 1552-5279

Titre abrégé: Alzheimers Dement

Pays: United States

ID NLM: 101231978

Informations de publication

Date de publication:
03 2019

Historique:

received: 16 04 2018

revised: 27 08 2018

accepted: 06 09 2018

pubmed: 20 10 2018

medline: 6 5 2020

entrez: 20 10 2018

Statut: ppublish

Résumé

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. 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. 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. AMYPAD-DPMS will supply physicians and health care payers with real-world data to plan management decisions.

Identifiants

DOI: 10.1016/j.jalz.2018.09.003 PMID: 30339801

pubmed: 30339801

pii: S1552-5260(18)33528-3

doi: 10.1016/j.jalz.2018.09.003

pii:

doi:

Substances chimiques

Amyloid 0

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

388-399

Commentaires et corrections

Type : ErratumIn