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Enrolling by invitation

NCT Number: NCT07768098

The Leuven Longitudinal Late-Life Depression Study

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.

Enrolling by invitation

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Flanders, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants Who Died

    Time frame: 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.

  2. Number of Participants with Dementia

    Time frame: 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.

Secondary outcomes

  1. Rate of depressive episodes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: L4D

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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