Late Life Depression (LLD)L4DNCT07768098
The Leuven Longitudinal Late-Life Depression Study
An observational study of Late Life Depression (LLD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Late Life Depression (LLD)
- How many people
- 178 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jul 2026to 31 Dec 2029
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Not applicable, since participants who met any exclusion criteria were already excluded from the previous studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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:
Read more
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.
- Conditions
- Late Life Depression (LLD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Late-life depression group | Same interventions in both groups | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Died
Measured: 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
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.
Measured: 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
Secondary outcomes (1)
Rate of depressive episodes
Hospitalisations for depression, referrals to psychotherapy or psychiatry, suicide attempts
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start30 Jul 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Late Life Depression (LLD)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768098
- Sponsor's protocol ID
- S71965
- Acronym
- L4D
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Winter FL, Emsell L, Bouckaert F, Claes L, Jain S, Farrar G, Billiet T, Evers S, Van den Stock J, Sienaert P, Obbels J, Sunaert S, Adamczuk K, Vandenberghe R, Van Laere K, Vandenbulcke M. No Association of Lower Hippocampal Volume With Alzheimer's Disease Pathology in Late-Life Depression. Am J Psychiatry. 2017 Mar 1;174(3):237-245. doi: 10.1176/appi.ajp.2016.16030319. Epub 2016 Aug 19.
PubMed 27539488Emsell L, Laroy M, Van Cauwenberge M, Vande Casteele T, Vansteelandt K, Van Laere K, Sunaert S, Van den Stock J, Bouckaert F, Vandenbulcke M. The Leuven late life depression (L3D) study: PET-MRI biomarkers of pathological brain ageing in late-life depression: study protocol. BMC Psychiatry. 2021 Jan 28;21(1):64. doi: 10.1186/s12888-021-03063-y.
PubMed 33509135
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Leuven Longitudinal Late-Life Depression Study
- ClinicalTrials.gov ID
- NCT07768098
- Acronym / sponsor ID
- L4D / S71965
- Conditions
- Late Life Depression (LLD)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late-life depression group | – | –Same interventions in both groups |
| Healthy controls | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable, since participants who met any exclusion criteria were already excluded from the previous studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 27539488De Winter FL, Emsell L, Bouckaert F, Claes L, Jain S, Farrar G, Billiet T, Evers S, Van den Stock J, Sienaert P, Obbels J, Sunaert S, Adamczuk K, Vandenberghe R, Van Laere K, Vandenbulcke M. No Association of Lower Hippocampal Volume With Alzheimer's Disease Pathology in Late-Life Depression. Am J Psychiatry. 2017 Mar 1;174(3):237-245. doi: 10.1176/appi.ajp.2016.16030319. Epub 2016 Aug 19.
- Background: PubMed 33509135Emsell L, Laroy M, Van Cauwenberge M, Vande Casteele T, Vansteelandt K, Van Laere K, Sunaert S, Van den Stock J, Bouckaert F, Vandenbulcke M. The Leuven late life depression (L3D) study: PET-MRI biomarkers of pathological brain ageing in late-life depression: study protocol. BMC Psychiatry. 2021 Jan 28;21(1):64. doi: 10.1186/s12888-021-03063-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late Life Depression (LLD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07768098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.