Pilot Study on Patients With Mild to Moderate Form of Alzheimer's Disease and Healthy Volunteers: Characterization of Intra-subject Variability and Chronobiological Variations of ADDIA Biomarkers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Blood cell biomarker level
研究概览
简要总结
The present single center clinical chronobiological study on 24 subjects (12 patients with mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be analyzed on samples taken at different time points of the day, including under fasting and non-fasting conditions and at two periods: day 1 and day 14.
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any subject who did not sign the informed consent form.
- •Any chronic neurodegenerative disease (vascular dementia, Parkinson's disease, Creutzfeldt Jacob, Huntington's disease, etc.), acute neurodegenerative disease (stroke), history or presence of clinically relevant psychiatric history (schizophrenia, psychosis), some chronic inflammatory diseases that impact blood cells (e.g. anemia of inflammation and chronic disease) and some cancers (that impact blood cells: e.g. leukemia), major sensory deficits that could interfere with cognitive assessment (visual and auditory), epilepsy.
- •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
- •Blood donation, any volume, within 2 months before inclusion.
- •Neutropenia (Neutrophils < 1500/mm3).
- •Thrombocytopenia (platelets: < 100,000/mm3, rule out EDTA-induced pseudothrombocytopenia).
结局指标
主要结局
Blood cell biomarker level
时间窗: Two weeks
To characterize the targeted blood cell biomarkers by assessing the effects of effect of meal, age and gender on biomarkers and changes in biomarker expression levels over two periods (day 1, day 15).
次要结局
- Circulating biomarker level(two weeks)