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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Места учебы
-
-
Flanders
-
Leuven, Flanders, Бельгия, 3000
- UZ Leuven
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
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.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
|
Здоровые элементы управления
|
|
Late-life depression group
Same interventions in both groups
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Participants Who Died
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rate of depressive episodes
Временное ограничение: 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.
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- S71965
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .