跳至主要内容
临床试验/NCT05781139
NCT05781139招募中不适用

Comparative Study Between Alzheimer's and Multi-infarct Dementia Regarding to Clinical Aspect, Biomarker, and Cortical Excitability

Assiut University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年3月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
1
主要终点
detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia )

研究概览

简要总结

Dementia is a neurological disease that causes cognitive and behavioral impairments that could ultimately interfere with the ability to function at work or to do the usual daily activities. It is recognized as a healthcare and social burden and remains challenging in terms of proper diagnosis and treatment.

详细描述

Biomarkers are needed to identify at-risk individuals, stage their disease, and track disease progression. Such biomarkers should be noninvasive, inexpensive, and simple to acquire. Neurodegeneration biomarkers in CSF include neurofilament light (NfL), Chitinase 3-like protein 1 (CHI3L1). NfL for example increases in several neurologic conditions, including AD. In addition, NfL can be detected in serum using standard immunoassay formats. Higher CSF levels of CHI3L1 are seen in patients with neurological disorders such as MS patients experiencing relapses of MS. In addition, C-X-C motif chemokine 13 (CXCL13) is a crucial homeostatic chemokine expressed in lymphoid organs, and it is essential for the recruitment and compartmentalization of lymphocytes. In MS, CXCL13 regulates homing of B cells and subsets of T cells to inflammatory foci in CNS by interacting with the CXCR5 receptor. The levels of CXCL13 are elevated in the CSF of patients with MS compared to healthy controls, as well as in other neuroinflammatory diseases. CXCL13 may be considered a CSF biomarker of intrathecal B cell response, as its levels correlate with the count of B cells, the IgG index, and the presence and OCBs in the CSF.

Transcranial magnetic stimulation (TMS) assesses several cortical properties such as excitability, plasticity, and connectivity in humans. TMS has been applied to patients with dementia, enabling the identification of potential markers of the pathophysiology and predictors of cognitive decline; moreover, applied repetitively, TMS holds promise as a potential therapeutic intervention.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women of at least 50-80 years of age.
  • Are reliable in individual data and willing to make themselves available for the duration of the study
  • Clear written informed consent obtained from 1st degree of relative from each patient participant and control himself in the trial.

排除标准

  • age below 50 years and above 80 years.
  • other neurological disorders or psychiatric disorders; previous history of stroke; metabolic disturbance; other major medical illnesses; epilepsy; inflammatory, autoimmune, or infectious disease; metallic objects in the body; craniotomy in the past.
  • Presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study
  • Participation in any other type of medical research that may interfere with the interpretation of the study.
  • Patients with severe motor disability (bed-ridden) that may interfere with the study procedure.
  • Patients with history of seizures or epilepsy including history in a first degree relative

结局指标

主要结局

detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia )

时间窗: 2 years

detect difference between multiple types of dementia (Alzheimer's disease with early onset, and late-onset as well as multi-infarct dementia ) regarding clinical profile, biomarkers, and cortical excitability

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AAEsraa

Assistant Lecturer

Assiut University

研究点 (1)

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