跳至主要内容
临床试验/NCT06855368
NCT06855368招募中不适用

Brain Connectivity and Complexity Parameters to Monitor Disease Progression in Dementia Patients and Antiinflammatory Nanotherapeutics in a Preclinical Model of Alzheimer's Disease

IRCCS San Raffaele Roma2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年5月18日最近更新:
适应症

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

研究者

发起方
IRCCS San Raffaele Roma
申办方类型
Other
责任方
Sponsor

研究点 (2)

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