Cohort Study for Early Identification of Markers in Cognitively Healthy Family Members of Patients With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 419
- 试验地点
- 1
- 主要终点
- Change from preclinical phase of AD to Mild Cognitive Impairment.
研究概览
简要总结
The ALFA study is a long term, prospective, observational study of AD patients' adult children aimed at studying and characterizing key physio-pathological features of the preclinical phase of AD.
详细描述
The natural history of AD includes an asymptomatic or preclinical phase characterized by pathological cerebral alterations without any evident symptoms of the disease. The beginning of the preclinical phase can be detected using a series of biological and neuroimaging markers that indicate the presence of Aβ deposition in the brain. A variety of factors such as inflammation, genetic load (e.g., APOE4), diet, cardiovascular risk, sleep disorders and cognitive reserve, produced by endogenous or exogenous factors, vary among individuals and may determine the beginning and evolution of the preclinical phase of the disease. It is possible to identify subclinical, biological, cognitive and neuroimaging changes, in the AD preclinical phase. The longitudinal study of intra-individual changes will be more sensitive than cross-sectional inter-individual studies to detect the cognitive evolution during the AD preclinical phase. Similarly, it would be possible to identify factors in subjects at the preclinical phase that will influence their evolution to the clinical stage of the disease.
The study will start with a screening of 3.000 recruited volunteers (NCT01835717) complying as much as possible with study selection criteria and perfectly aware of the study needs.
The selected 400 participants fulfilling the inclusion criteria will undergo detailed phenotyping consisting in: clinical history, AD family history, full cognitive evaluation, cognitive reserve determination, CSF sample collection, blood and urine sample collection, neuroimaging (MRI), quality of life and habits of life questionnaires (physical activity, diet, sleeping habits, social activity, toxics habits, pollution exposure).
The longitudinal study will consist in a every 3-year follow-up visit in which the participant will undergo a review of the clinical history data, a full cognitive evaluation, neuroimaging (MRI), samples collection (blood, urine, CSF) and update of the life habits changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult children of AD patient: First-degree descendant of an AD patient (following diagnosis as define in protocol).
- •Age: 45 to 64 years old.
- •Long-term commitment to the study: baseline and follow-up visits. Potential participants have to agree to undergo to all the procedures described in the protocol.
排除标准
- •Cognitive impairment: to be included the participant must show no signs of objective cognitive impairment.
- •Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
- •Illiteracy or functional illiteracy.
- •Any contraindication to any test or procedure at the time of study inclusion.
- •Family history of monogenic AD.
- •Not willing to undergo one or more of the tests and procedures described in the protocol at baseline.
结局指标
主要结局
Change from preclinical phase of AD to Mild Cognitive Impairment.
时间窗: Every 3 years, from date of inclusion until the date of first documented progression, fulfilling mild cognitive impairment criteria, or date of death from any cause, whichever came first, assessed up to 12 years.
次要结局
未报告次要终点