Laboratory of Neuroimaging of Aging (LANVIE), University of Geneva, Geneva, Switzerland; Memory Clinic, University Hospital of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), Saint John of God Clinical Research Centre, Brescia, Italy.
Department of Radiology and Nuclear Medicine, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, the Netherlands; Institutes of Neurology and Healthcare Engineering, UCL, London, United Kingdom.
Alzheimers Dement. 2019 Mar;15(3):388-399. doi: 10.1016/j.jalz.2018.09.003. Epub 2018 Oct 16.
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.
由于缺乏关于其临床效用和成本效益的明确证据，淀粉样蛋白正电子发射断层扫描（PET）的报销滞后。淀粉样蛋白成像预防阿尔茨海默病-诊断和患者管理研究（AMYPAD-DPMS）旨在填补这一空白。
AMYPAD-DPMS 是一项 4 期、多中心、前瞻性、随机对照研究。900 名有主观认知减退、轻度认知障碍和可能因阿尔茨海默病导致的痴呆的患者将被随机分为 ARM1、在诊断工作中早期进行淀粉样蛋白-PET；ARM2、在 8 个月后进行淀粉样蛋白-PET；和 ARM3、只要医生选择，就进行淀粉样蛋白-PET。
主要终点是在 3 个月后，ARM1 和 ARM2 之间接受高度置信病因诊断的患者比例差异。次要终点涉及诊断和诊断信心、诊断/治疗管理、健康经济学和患者相关结果，以及图像定量方法。
AMYPAD-DPMS 将为医生和医疗保健支付者提供真实世界的数据，以规划管理决策。
