- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02814422
Triglyceride-rich Lipoprotein and Development of Dementia
Triglyceride-rich Lipoprotein and the Development of Dementia
Because of the rapid aging of the global population, dementia has become a serious problem, and Alzheimer's disease (AD) is the most common cause of dementia. AD is pathologically characterized by substantial neuronal loss and chronic inflammation that is associated with cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in amyloid-beta (Aβ). More recent evidence shows it is due to an increased blood-to-brain delivery of circulating Aβ, and significant peripheral Aβ metabolism occurs in association with post-prandial triglyceride-rich lipoproteins.
In the prodromal stage of AD, patients usually suffer mild cognition impairment (MCI). The annual conversion rate of MCI to AD is around 10%, and within 3 years, around 30%-50% of these develop dementia. Brain atrophy is an irreversible brain disease that causes problems with cognitive and memory functions in many diseases, such as MCI and AD, etc. In order to allow preventive intervention for AD, MCI must be diagnosed as early as possible, using biomarker assays or simple imaging modality. From 2009-2013, the investigators have registered 4,492 patients with atherosclerotic vascular diseases (AVD). In addition, the investigators have also registered 8,209 cases with no evidence of AVD, but with at least 1 cardiovascular risk factor. In this 5-year project, 300 male or female patients with stable symptomatic AVD over 20 years of age, and the other 600 patients with no evidence of AVD but with at least 1 CV risk factor, will be enrolled from our previous registry program. The baseline and yearly follow-up study will include clinical examination, neurocognitive function evaluation, and laboratory tests (TC, HDL-C, LDL-C, TG, hs-CRP, and Aβ-40, Aβ-42, tau protein, and other biological signatures: adiponectin, MMP-3, MMP-9, IL-6, Fibrinogen, Lp-PLA2, 8-Isoprostane, hFABP, sVCAM-1, sICAM-1, CA-125, MCP-1, TNF-α, cTnI, NT-proBNP, CNP, NGAL).
The purposes of this 5-year project are (1) to clarify the association of triglyceride-rich lipoprotein and the development of dementia; (2) to validate the diagnostic power and prognostic implication of ultra-low-concentration biomarkers (Aβ-40, Aβ-42 and tau) for dementia.
Обзор исследования
Статус
Условия
Подробное описание
Because of the rapid aging of the global population, dementia has become a serious problem, and Alzheimer's disease (AD) is the most common cause of dementia. Population studies have shown that dietary fats influence risk and progression of age-related diseases including AD, diabetes and cardiovascular disease. Consumption of saturated fat, trans-fatty acids and cholesterol are positively associated with increased risk. These findings support the hypothesis that dietary saturated-fats (SFA) and cholesterol, or dietary induced dyslipidemia are causally associated with AD risk. AD is pathologically characterized by substantial neuronal loss and chronic inflammation that is associated with cerebrovascular and parenchymal accumulation of proteinaceous deposits enriched in amyloid-beta (Aβ). More recent evidence shows it is due to an increased blood-to-brain delivery of circulating Aβ, and significant peripheral Aβ metabolism occurs in association with post-prandial triglyceride-rich lipoproteins.
In the prodromal stage of AD, patients usually suffer mild cognition impairment (MCI). The annual conversion rate of MCI to AD is around 10%, and within 3 years, around 30%-50% of these develop dementia. Brain atrophy is an irreversible brain disease that causes problems with cognitive and memory functions in many diseases, such as MCI and AD, etc. In order to allow preventive intervention for AD, MCI must be diagnosed as early as possible, using biomarker assays or simple imaging modality. From 2009-2013, the investigators have registered 4,492 patients with atherosclerotic vascular diseases (AVD). In addition, the investigators have also registered 8,209 cases with no evidence of AVD, but with at least 1 cardiovascular risk factor. In this 5-year project, 300 male or female patients with stable symptomatic AVD over 20 years of age, and the other 600 patients with no evidence of AVD but with at least 1 CV risk factor, will be enrolled from our previous registry program. The baseline and yearly follow-up study will include clinical examination, neurocognitive function evaluation, and laboratory tests (TC, HDL-C, LDL-C, TG, hs-CRP, and Aβ-40, Aβ-42, tau protein, and other biological signatures: adiponectin, MMP-3, MMP-9, IL-6, Fibrinogen, Lp-PLA2, 8-Isoprostane, hFABP, sVCAM-1, sICAM-1, CA-125, MCP-1, TNF-α, cTnI, NT-proBNP, CNP, NGAL).
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Контакты исследования
- Имя: Wan T Ke
- Номер телефона: 88558 886-2-23123456
- Электронная почта: t87134@gmail.com
Места учебы
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Taipei, Тайвань
- Рекрутинг
- NTUH
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- age older than 20 years old
- willing to sign ICF
- report oneself disease
- have Taiwanese ID
- atherosclerotic vascular diseases, but with at least 1 CV risk factor [DM, dyslipidemia or under lipid lowering therapy, hypertension, smoking, old (M>45, F>55 years), family history of premature CAD, obesity
Exclusion Criteria:
- not willing to sign ICF
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Композитный сердечно-сосудистый исход
Временное ограничение: до 5 лет
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Составным сердечно-сосудистым (СС) исходом будут любые сердечно-сосудистые события (коронарные, церебральные или периферические сосудистые заболевания).
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до 5 лет
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Наличие как минимум 1 сердечно-сосудистого фактора риска.
Временное ограничение: до 5 лет
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отсутствие признаков атеросклеротических заболеваний сосудов с наличием хотя бы 1 сердечно-сосудистого фактора риска.
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до 5 лет
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 201407002RIND
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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. .