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临床试验/NCT05562596
NCT05562596尚未招募不适用

Liquor Oxysterols Concentrations as Biomarkers in Idiopathic Normal Pressure Hydrocephalus

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Oxysterol levels in peripheral and central brain liquor

研究概览

简要总结

Normal Pressure Hydrocephalus (NPH) is a clinical condition that induces cognitive deterioration that can be reverted, at least in part, by introducing ventricular-peritoneal diversion controlled by a miniaturized valve system.

Mechanisms involved in such an improvement of cognitive function after liquor diversion are unknown.

Oxysterols are a family of cholesterol-related compounds having diverse biological functions. Among others, they are involved in cholesterol homeostasis in the brain and are detectable in liquor, potentially impacting neurodegeneration.

NPH is an ideal clinical model to study oxysterol distribution in liquor before and after ventricular-peritoneal diversion.

详细描述

Normal-pressure hydrocephalus (NPH) is a progressive, chronic, and extremely complex syndrome, firstly described in 1957, which represents the most common form of reversible dementia in the elderly.

The onset of NPH is on average in the seventh decade of life, with a slightly higher prevalence in males, and the Adam-Hakim triad, which includes dementia, urinary incontinence, and gait deviations, constitutes its clinical mainstay.

Clinical manifestations of NPH are hard to notice, especially at the onset, and the patient itself may not grasp the presence of early signs of NPH until a major event - a fall, for example, occurs.

Diagnosis of NPH is made upon clinical and radiological data and on the effectiveness of cerebrospinal fluid (CSF) shunting by ventricular diversion.

Mechanisms involved in the development of NPH are mainly unknown. Oxysterols are sterol compounds congeners of cholesterol with diverse biological properties. Some of them are linked to cholesterol trafficking in the brain - e.g. 24S-hydroxycholesterol (24S-HC) that allows the transport of cholesterol from the brain to the liver, and are supposedly implicated in neurodegenerative diseases. Evaluation of CSF oxysterols concentration in patients diagnosed with NPH constitutes the primary objective of this study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of NPH

排除标准

  • Patients with a non-performing ASA score to the intervention

结局指标

主要结局

Oxysterol levels in peripheral and central brain liquor

时间窗: 2 months

Comparison between values of quantitative analysis of oxysterols in liquor collected at time of spinal and central liquor obtained at spinal tap and ventricular drainage

Correlation between oxysterol levels in the peripheral and central liquor and MMSE score

时间窗: 2 months

Evaluation of potential correlation between oxysterol levels and mini-mental status examination score.

次要结局

未报告次要终点

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Iuliano

Professor of Internal Medicine

University of Roma La Sapienza

研究点 (1)

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