AMYPAD Prognostic and Natural History Study (PNHS), an open label, prospective, multicentre, cohort study in individuals without dementia to evaluate the additional value of quantitative amyloid imaging in determining Alzheimer’s Disease (AD) dementia risk - AMYPAD PNHS

Stichting VUmc0 个研究点目标入组 2,000 人开始时间: 2018年6月25日最近更新: 2021年11月3日

适应症

试验速览

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•1.Current or former participants of a Sponsor-approved PC, not demented, and older than 50 years of age will be eligible if they provide separate written informed consent to participate in the AMYPAD PNHS.
•2.Participants with a suitable baseline biomarker, cognitive and risk factor profile, as determined by the Selection and Feasibility Committee, based on an adaptive selection algorithm that aims to provide optimal representation of the probability spectrum for AD risk; OR participants that have been randomly selected to maintain a mandated non-disclosure policy.
•3.Participants who are assessed by the recruiting investigator to be physically fit to undergo PET scanning and able to tolerate the PET scanning procedure for at least the duration of a static scan (20 minutes).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 800

•1.Participants in whom PET scanning or magnetic resonance imaging (MRI) are contraindicated.
•2.Participants who are not able to complete the study procedures as judged by the investigator.
•3.Participants who have known hypersensitivities to the active ingredients of [18F]flutemetamol and [18F]florbetaben, or the excipients for both products (listed in section 6.1 of the respective Summary of Product Characteristics [SPC]).
•4.Women of childbearing potential who are pregnant, planning to become pregnant, lactating, or do not follow the contraceptive methods recommended by the Clinical Trial Facilitation Group

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