EUCTR2018-002277-22-ES进行中（未招募）1 期
AMYPAD Prognostic and Natural History Study (PNHS), an open label, prospective, multicentre, cohort study linked to the European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS) in individuals without dementia to evaluate the additional value of quantitative amyloid imaging in determining Alzheimer's Disease (AD) dementia risk - AMYPAD PNHS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Baseline Eligibility Criteria
- •1. Participants who are currently active in the EPAD LCS 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 the mandated
- •nondisclosure EPAD LCS.
- •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).
- •Follow-up Eligibility Criteria
- •1. Participants who underwent dynamic PET scanning at baseline:
- •a. Participants who are willing and available to undergo a follow-up
- •scan. All participants with a dynamic scan at baseline will be invited for
- •follow-up scans.
- •2. Participants who underwent static PET scanning at baseline:
- •a. Participants who are willing and available to undergo a follow-up
- •b. Are selected based on the Selection and Feasibility Committee's
- •algorithm for follow-up, which in addition to the previous algorithm also
- •considers baseline composite SUVR values.
- •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 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1200
排除标准
- •1. Participants who are not currently active in the EPAD LCS.
- •2. Participants in whom PET scanning or magnetic resonance imaging (MRI) are contraindicated.
- •3. Participants who are not able to complete the study procedures as judged by the investigator.
- •4. 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]).
- •5. Women who are pregnant, planning to become pregnant, or lactating.
研究者
相似试验
已完成
Unknown
Prognostic Model for Resected Borderline and Locally Advanced Pancreatic Cancer after Neoadjuvant ChemotherapyNeoplasmsKCT0009203Asan Medical Center176
尚未招募
不适用
Prediction of survival by physicians and assessment of symptoms in patients with liver, pancreatic and gallbladder cancers in a palliative care settingCTRI/2022/08/044932Tata Memorial Hospital
招募中
不适用
Translational Research of Inflammatory Bowel Disease in KoreaDiseases of the digestive systemKCT0000545Asan Medical Center7,500
已完成
不适用
Observational study about the prognostic implication of chromosomal and genetic alterations in adult acute myeloid leukemia. -JALSG AML209 Genetic Study (AML209-GS)Adult acute myeloid leukemiaJPRN-UMIN000003432Japan adult leukemia study group1,826
招募中
不适用
Retrospective analysis to identify prognostic parameters for response to immune checkpoint blockade in non small cell lung cancer patientsC34Malignant neoplasm of bronchus and lungDRKS00012643niversitätsklinikum TübingenMedizinische Klinik II200