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The Leuven Longitudinal Late-Life Depression Study (L4D)

2026年8月14日 更新者:Universitaire Ziekenhuizen KU Leuven

The goal of this observational study is to learn about the long-term effects of late-life depression (LLD) in adults aged 60 and older. LLD is depression that begins for the first time later in life. Patients with this condition may feel sad for a long time or lose interest in activities they used to enjoy. They may also have problems with sleep, energy, or concentration. In some patients, this depression comes with changes in thinking and memory, which may be linked to a higher risk of dementia.

The investigators believe that changes in the brain play a role in this condition. The main questions this study aims to answer are:

Do patients with late-life depression have a higher risk of memory decline, dementia, return of depression, hospital stays, or death compared to healthy people? Can brain scans and blood tests help predict how the illness will develop over time?

The investigators will compare patients with late-life depression to healthy people of the same age and sex. This will help clarify how the illness develops over several years.

This is a follow-up study, which means no new treatment is being tested. The investigators will recruit participants from previous studies, drawn from two cohorts with a mean follow-up time since inclusion of 12 years and 6 years. The investigators collect information about health, memory, and mood, and compare it with earlier measurements. To do this, the investigators use existing information from past studies, medical records, brain scans, and blood samples.

Participants can take part if they:

Are at least 60 years old Took part in one of the earlier studies Give written permission to join

Participants may be asked to:

Have a conversation and take memory tests Give a blood sample Have a brain scan

These tests can take place in the hospital or at the participant's home. If a participant does not want to do the tests again, the investigators can ask their family doctor for important health information, with the participant's permission.

研究概览

地位

邀请报名

研究类型

观察性的

注册 (估计的)

178

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。

学习地点

    • Flanders
      • Leuven、Flanders、比利时、3000
        • UZ Leuven

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

  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Participants are adults aged 60 years and older who took part in one of the earlier related studies. This group includes people diagnosed with late-life depression as well as healthy adults of the same age and sex who serve as a comparison group.

Participants are recruited from the existing cohort of these earlier studies, using their prior study data, medical records, brain scans, and blood samples. Participants will be asked to return for follow-up assessments, which can take place in the hospital or at their home.

描述

Inclusion Criteria:

  • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  • At least 18 years of age at the time of signing the Informed Consent Form (ICF).
  • Participants were included in the previous studies.

Exclusion Criteria:

  • Not applicable, since participants who met any exclusion criteria were already excluded from the previous studies.

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

队列和干预

团体/队列
健康控制
Late-life depression group
Same interventions in both groups

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
Number of Participants Who Died
大体时间:From enrollment in the initial cross-sectional study until date of death from any cause, assessed up to 12 years for cohort 1 and up to 6 years for cohort 2.
From enrollment in the initial cross-sectional study until date of death from any cause, assessed up to 12 years for cohort 1 and up to 6 years for cohort 2.
Number of Participants with Dementia
大体时间:From enrollment in the initial cross-sectional study to the follow-up assessment, an average of 12 years for cohort 1 and 6 years for cohort 2
Participants with a MMSE score lower or equal to 10, and a CDR scale score higher or equal to 2, will be classified as having dementia.
From enrollment in the initial cross-sectional study to the follow-up assessment, an average of 12 years for cohort 1 and 6 years for cohort 2

次要结果测量

结果测量
措施说明
大体时间
Rate of depressive episodes
大体时间:From enrollment in the initial cross-sectional study to the follow-up assessment, an average of 12 years for cohort 1 and 6 years for cohort 2. If deceased, up until passing away.
Hospitalisations for depression, referrals to psychotherapy or psychiatry, suicide attempts
From enrollment in the initial cross-sectional study to the follow-up assessment, an average of 12 years for cohort 1 and 6 years for cohort 2. If deceased, up until passing away.

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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 (实际的)

2026年7月30日

初级完成 (估计的)

2026年8月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月17日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • S71965

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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

在美国制造并从美国出口的产品

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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