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临床试验/NCT06354933
NCT06354933已完成不适用

Neurological Soft Signs in Neurodegenerative Dementias

University of Milano Bicocca1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
1
主要终点
Difference in NSS

研究概览

简要总结

The goal of this observational study is to investigate the prevalence of Neurological Soft Signs (NSS) in various categories of dementia patients compared to matched controls. The main questions it aims to answer are:

  • Does the prevalence of NSS significantly differ among patients with neurodegenerative dementias compared to controls?
  • Are NSS associated with neuropsychiatric alterations in dementia patients?
  • Do NSS correlate with cognitive screening tools?
  • Do NSS increase over time in patients with neurodegenerative dementias?

Participants will undergo assessments including:

  • Evaluation of NSS using the Heidelberg scale
  • Neuropsychiatric assessments
  • Cognitive screening using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB)

Researchers will compare dementia groups (Alzheimer's disease, Frontotemporal dementia, Corticobasal syndrome and Lewy body dementia) to controls to determine differences in NSS prevalence. Additionally, associations between NSS and neuropsychiatric symptoms, as well as cognitive performance, will be explored.

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

入选标准

  • Diagnosis of probable Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), Corticobasal Syndrome (CBS), or probable Lewy Body Dementia (LBD) according to established clinical criteria.
  • MMSE score greater than
  • Age and gender-matched controls without a history of neurological or psychiatric conditions.

排除标准

  • Mixed dementia or vascular etiology.
  • History of neurological or psychiatric conditions predating the dementia diagnosis.
  • Substance or alcohol abuse history.
  • Known comorbidities affecting neurological or psychiatric function.
  • MMSE score less than or equal to
  • Inability to provide informed consent.

结局指标

主要结局

Difference in NSS

时间窗: 0 days (baseline)

Difference in Neurological Soft Signs according to the Heidelberg manual between neurodegenerative dementias and controls (range 0-48, higher scores indicate worse performance)

次要结局

  • Correlation between NSS scores and cognitive function assessed by Frontal Assessment Battery (FAB)(0 days (baseline))
  • Longitudinal changes in NSS scores(12 months)
  • Association between NSS and Neuropsychiatric Inventory (NPI) scores(0 days (baseline))
  • Correlation between NSS scores and cognitive function assessed by Mini-Mental State Examination (MMSE)(0 days (baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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