- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Flanders
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Leuven, Flanders, 벨기에, 3000
- UZ Leuven
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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건강한 통제
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Late-life depression group
Same interventions in both groups
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Who Died
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of depressive episodes
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- S71965
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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