Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Presence of Alzheimer-specific blood biomarkers
研究概览
简要总结
Alzheimer's disease is a degenerative condition affecting the brain and is the most common form of dementia in older adults. Dementia is currently a major healthcare issue in the UK, affecting approximately a million people. The progression of the disease varies between individuals and the early stages may be characterised by only minimal changes in memory and thinking. These changes could remain undetected as the symptoms may be mistakenly regarded as normal age-related forgetfulness. However, dementia is not part of the normal ageing process.
The underlying biological disease process of Alzheimer's is now known to start at least 20 years prior to patients showing any symptoms. A protein called amyloid starts to deposit in the brain and forms clumps referred to as 'plaques'. Another protein called tau collects inside brain cells and forms structures called 'tangles'. These biological changes can disrupt the normal functioning of brain cells and ultimately destroy them, leading to a reduction in brain volume and ability.
The aim of the BEAD-PC study is to assess whether a specific blood test in primary care can help diagnose Alzheimer's disease at an early stage.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 55 years and above
- •Presence of self-reported symptoms indicative of cognitive decline or concerns family members/partners indicative of cognitive decline
- •Capacity to consent
- •Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.
排除标准
- •Insufficient vision and hearing
- •Prior diagnosis of ADRD. Prior diagnosis of Alzheimer's disease or related dementia (with or without evidence of pathology), through clinical diagnosis and/or as documented in their medical record
- •Pre-existing diagnosis of dementia
- •Incidental findings of brain pathologies on brain MRI, such as cancerous space occupying lesions and clinically significant vascular malformations and recent (within 12 months) macro-infarcts, that are, also exclusionary
- •Contraindication for Lumbar Puncture
- •Involvement in interventional research study within 3 months prior to screening
- •For any other reason, in the opinion of the Investigator, participating in the study is not in the best interest of the patient.
结局指标
主要结局
Presence of Alzheimer-specific blood biomarkers
时间窗: Day 1 (study entry)
Amyloid and Tau protein biomarkers identified in blood sample
Presence of Alzheimer-specific Cerebrospinal Fluid (CSF) biomarkers
时间窗: Follow-up visit (around 6 months after study entry)
Amyloid and Tau protein biomarkers found in CSF
次要结局
- Montreal Cognitive Assessment (MoCA) score(Day 1 (study entry))
- CANTAB score(Day 1 (study entry))