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Mild Cognitive Impairment in Older Adults With and Without Depressive Symptom

2026年11月5日 更新者:University Medical Centre Maribor

Factors Differentiating Older Adults With Mild Cognitive Impairment and Depressive Symptoms From Those With Mild Cognitive Impairment Without Depressive Symptoms

This study will compare adults aged 65 years or older who have mild cognitive impairment, with and without depressive symptoms. The researchers plan to participants at University Medical Centre Maribor, with two equally sized groups. They will compare outcomes in several different cognitive domains (visuospatial abilities, emotional modulation, social cognition) and in DNA methylation of relevant regions (for BDNF, COMT, and SLC6A4 gene promoters).

研究概览

详细说明

This cross-sectional observational study will examine cognitive and epigenetic differences between older adults with mild cognitive impairment who have depressive symptoms and those who do not. Potential participants will be identified through the outpatient psychogeriatric, psychiatric, and neurology clinics and the inpatient geriatric psychiatry units at University Medical Centre Maribor. Participants will be aged 65 years or older, have cognitive screening results consistent with mild cognitive impairment, and provide written informed consent. The planned sample will include two equally sized groups of participants.

Participants will be classified according to the presence or absence of depressive symptoms at the initial assessment. Depressive symptoms will be reassessed early in the study to confirm group classification. Participants will receive the same standard of diagnostic assessment and treatment as patients who do not take part in the study.

The study will compare performance on tasks assessing visuospatial abilities, emotional modulation abilities and social cognition. The investigators hypothesize that participants with depressive symptoms will perform better on the visuospatial task and less well on the emotional capture and social cognition tasks than participants without depressive symptoms. Blood samples will be collected to compare DNA methylation in the promoter regions of BDNF, COMT, and SLC6A4 between the two groups.

研究类型

观察性的

注册 (估计的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study population will consist of adults aged 65 years or older with cognitive screening results consistent with mild cognitive impairment. Potential participants will be identified at University Medical Centre Maribor through the outpatient psychogeriatric, psychiatric, and neurology clinics and the inpatient geriatric psychiatry units. The planned sample includes equal numbers of participants with depressive symptoms without depressive symptoms.

描述

Inclusion Criteria:

  • Age 65 years or older.
  • Receiving outpatient or inpatient psychiatric care with a working diagnosis of a mood, anxiety, or cognitive disorder.
  • Cognitive screening results consistent with mild cognitive impairment.
  • Written informed consent to participate in the study.

Exclusion Criteria:

  • Established diagnosis of Alzheimer's disease or another specific form of dementia.
  • Established diagnosis of another specific neurological or neurodegenerative disease.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
Mild Cognitive Impairment With Depressive Symptoms

Adults aged 65 years or older with mild cognitive impairment and depressive symptoms, as determined by the study's depression assessment.

Mild Cognitive Impairment Without Depressive Symptoms

Adults aged 65 years or older with mild cognitive impairment without depressive symptoms, as determined by the study's depression assessment.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Visuospatial Task Performance
大体时间:At the baseline study visit.

Visuospatial performance will be measured using computer guided cognitive task (n-back). Values will be compared between participants with mild cognitive impairment with and without depressive symptoms.

At the baseline study visit.
Emotional Capture Task Performance
大体时间:At the baseline study visit.

Emotional capture will be assessed using the computer guided Emotional Capture Task. Values will be compared between participants with mild cognitive impairment with and without depressive symptoms.

At the baseline study visit.
Social Cognition Performance on the Faux Pas Test
大体时间:At the baseline study visit.

Social cognition will be assessed using the Faux Pas Test. Scores will be compared between participants with mild cognitive impairment with and without depressive symptoms.

At the baseline study visit.
Regional DNA Methylation (BDNF, COMT and SLC6A4 promoter gene regions)
大体时间:At the baseline study visit.

DNA methylation will be measured in target regions using DNA obtained from blood samples. Results will be compared between participants with mild cognitive impairment with and without depressive symptoms.

At the baseline study visit.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月23日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2028年6月30日

研究注册日期

首次提交

2026年11月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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