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临床试验/NCT06179680
NCT06179680招募中不适用

Quantification of White Matter Hyperintensities in Subjects With Amnestic Mild Cognitive Impairment or Alzheimer's Disease

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2022年7月21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
142
试验地点
1
主要终点
White Matter Hyperintensity burden

研究概览

简要总结

This study focuses on assessing and measuring white matter hyperintensities in individuals with amnestic mild cognitive impairment (aMCI) or Alzheimer's disease.

Objective:

The primary objective of the study is to quantify the extent and distribution of white matter hyperintensities in the brains of individuals diagnosed with amnestic mild cognitive impairment or Alzheimer's disease. White matter hyperintensities are areas of increased signal intensity observed on brain magnetic resonance imaging (MRI) scans, often associated with various cognitive disorders.

Importance:

Understanding the presence and severity of white matter hyperintensities in individuals with aMCI or Alzheimer's disease is crucial for several reasons. These abnormalities may serve as potential biomarkers, aiding in the early diagnosis and prognosis of cognitive disorders. Additionally, quantifying white matter hyperintensities could contribute to a better comprehension of the underlying neuropathological processes associated with these conditions.

Methods:

The study employs advanced imaging techniques, likely including MRI, to capture and analyze white matter hyperintensities in the brains of participants with amnestic mild cognitive impairment or Alzheimer's disease. The quantification process involves precise measurement and mapping of these hyperintense regions.

Participants:

The study involves individuals diagnosed with amnestic mild cognitive impairment or Alzheimer's disease. Participants will undergo neurological assessments and imaging procedures to facilitate the accurate measurement of white matter hyperintensities.

Expected outcomes:

Researchers anticipate that the quantification of white matter hyperintensities will provide valuable insights into the progression of cognitive disorders. The results may contribute to the development of more targeted and effective diagnostic and therapeutic interventions for individuals with amnestic mild cognitive impairment or Alzheimer's disease.

Conclusion:

This study represents a significant step toward enhancing our understanding of the neuropathological changes associated with amnestic mild cognitive impairment and Alzheimer's disease. By focusing on the quantification of white matter hyperintensities, researchers aim to uncover potential markers for early detection and monitoring of these cognitive disorders.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants diagnosed with amnestic Mild Cognitive Impairment (aMCI) or Alzheimer's Disease (AD) based on clinical assessments.
  • Individuals undergoing brain magnetic resonance imaging (MRI) at the IRCCS Policlinico San Donato as part of routine diagnostic procedures.
  • Age-matched and gender-matched healthy control subjects for comparison.

排除标准

  • Individuals with cognitive impairment other than amnestic MCI or AD.
  • History of significant neurological disorders (other than MCI or AD) that may impact the study outcomes.
  • Presence of contraindications for undergoing MRI procedures.
  • Any serious medical or psychiatric condition that, in the judgment of the researchers, may interfere with the study participation or compromise the validity of the results.
  • Known history of alcohol or substance abuse that may affect cognitive function.
  • Inability or unwillingness to provide informed consent.

结局指标

主要结局

White Matter Hyperintensity burden

时间窗: 24 months

The primary objective is to study the difference in terms of White Matter Hyperintensity (WMH) burden normalized for intracranial volume (primary outcome) between patients with Alzheimer's Disease (AD) and control subjects. This forms the basis for calculating the sample size for prospective recruitment.

次要结局

  • TRACE4AD classifier(24 months)
  • Spatial distribution pattern(24 months)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Sardanelli

Prof.

IRCCS Policlinico S. Donato

研究点 (1)

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