Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Identification of Disease-Associated Phenotypes in MCI and AD
研究概览
简要总结
The variable course of Alzheimer's disease (AD) and the paucity of adequate cures urges to implement new strategies for its early detection and clinical intervention. Studying the etiopathogenesis and pathophysiological mechanisms of AD is a necessary prerequisite for the development of new biomarkers and innovative therapies. Contrarily to anatomical structures, cortical connectivity networks are already deteriorated in early AD and could be a reliable marker of early cognitive decline. Our aim is to characterize the neurophysiological parameters in mild AD, in patients with mild cognitive impairment and in matched healthy subjects to identify discriminating criteria. Concurrently, the study of AD onset and progression in a mouse model, will allow evaluating the causal effect of inflammation on disease progression and to develop a new class of biomimetic anti-inflammatory nanoparticles formulated to have the intrinsic ability to induce brain's activated microglia to an M2 phenotype.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild AD and patients with mild cognitive impairment (MCI).
排除标准
- •major psychosis, genetic, metabolic and other neurological disorders, acute or chronic non-compensated medical illness
- •any medical or drug-related condition affecting cognitive or mood status
- •history or current alcohol/illicit drug abuse.
结局指标
主要结局
Identification of Disease-Associated Phenotypes in MCI and AD
时间窗: through study completion, an average of 1 year
Identification of Disease-Associated Early Interventions in MCI and AD
时间窗: through study completion, an average of 1 year
Predictive Power of EEG-Based Brain Network Analyses for MCI to AD Conversion
时间窗: through study completion, an average of 1 year
EEG power spectral density
Evaluation of Targeting Efficiency of Activated vs Native Leukosomes in Brain Inflammation
时间窗: through study completion, an average of 1 year
Evaluation Trafficking Kinetics of Activated vs Native Leukosomes in Brain Inflammation
时间窗: through study completion, an average of 1 year
Assessment of Activated Leukosomes in Inducing Anti-Inflammatory Polarization of Macrophages
时间窗: through study completion, an average of 1 year
Assessment of Activated Leukosomes in Glial Cells
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
