ISRCTN11126399进行中（未招募）Unknown
PREDICTOM: Evaluation and validation of a biomarker screening platform to identify risk of Alzheimer's disease at point of care
Stavanger University Hospital0 个研究点目标入组 4,615 人开始时间: 2024年4月18日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,615
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Adults aged 50 years or above
- •2. Access to a computer (or touchscreen device) and the internet
- •3. Participant is willing and able to give informed consent for participation in the study
- •4. In the UK and Norway, already an active participant in the PROTECT-UK or PROTECT-Norge cohort respectively
- •5. Willing and able to visit one of the PREDICTOM research centres
- •6. Symptoms or risk profile indicating an increased risk of AD or related disorders, operationalized as having at least one of the below:
- •6.1. Subjective cognitive complaints
- •6.2. AD or dementia in a first-degree relative
- •6.3. At least one cardiometabolic disorder known to be a risk factor for dementia (e.g. diabetes, obesity, hypertension, hypercholesterolemia, cerebrovascular disease or coronary disease or peripheral arterial disease)
- •Criteria for high and low risk will be defined based on a machine learning algorithm based on retrospective data from existing datasets and refined with data from the Cohort 1 assessments and sampling. Thresholds will be set for high and low risk within a centralised dataset. The exact algorithm will be developed and completed prior to the first participant completing Level 1 testing. Criteria will include:
- •1. Relative risk scores for each of the 12 modifiable risk factors from the Lancet Commission (1)
- •2. Family history of dementia.
- •3. APOE genotype
- •4. Cognitive test performance from Cohort 1 testing
- •5. Blood biomarkers from finger prick blood test performed in Cohort 1
- •6. Data from other relevant Level 1 tests.
- •7. Willing and able to give informed consent for the Cohort 2 protocol
排除标准
- •1. An established diagnosis of dementia
- •2. Life-threatening physical disease
- •3. Active major psychiatric disorder which is inconsistent with being able to complete informed consent or perform the procedures
- •4. Unable to speak native tongue
- •5. Neurodevelopmental disorder, sensory or other physical impairment or other factor making the person unable to complete the study procedures
- •6. Major disabling stroke, e.g., clinically significant symptoms and/or functional impairment
研究者
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