- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07768098
The Leuven Longitudinal Late-Life Depression Study (L4D)
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Flanders
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Leuven, Flanders, Belgio, 3000
- UZ Leuven
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Controlli sani
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Late-life depression group
Same interventions in both groups
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Participants Who Died
Lasso di tempo: 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.
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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.
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Number of Participants with Dementia
Lasso di tempo: 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
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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.
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Rate of depressive episodes
Lasso di tempo: 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.
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Hospitalisations for depression, referrals to psychotherapy or psychiatry, suicide attempts
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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.
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- Emsell 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- S71965
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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