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Идёт набор NCT06164262

Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years

— Наблюдательное Cerebral Small Vessel Diseases Dementia, Mixed Health Behavior Health Behavior, Risky

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Individuals with CSVD.
Кому может быть актуально
Состояния в реестре: Cerebral Small Vessel Diseases, Dementia, Mixed, Health Behavior, Health Behavior, Risky. Базовые параметры: 30 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）

Обзор

Age-related cerebral small-vessel disease (CSVD) is a major cause of dementia, predominantly affecting individuals over 60 years of age, with a prevalence exceeding 70% in the elderly population. However, the correlation between the burden of CSVD and the progression of cognitive impairment in young and middle-aged individuals remains uncertain. DREAM-10 is an observational, prospective study that enrolled individuals aged 30-60 years, who were free from known dementia but exhibited imaging markers related to CSVD. Through prospective registration and follow-up, this study will collect data on patients with CSVD, including clinical information, neuropsychological assessments, multimodal Magnetic Resonance Images (MRI) and retinopathy characterized by Optical Coherence Tomography Angiography (OCTA). CSVD related features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, brain atrophy, cortical superficial siderosis. Utilizing this data, the researchers aim to investigate the potential dementia risk among young and middle-aged individuals with CSVD over the forthcoming decade, along with identifying its predictive factors.

Вмешательства

  • Другое Individuals with CSVD
    This does not entail the application of interventions.

Первичные конечные точки

  • Mini-mental State Examination (MMSE) score [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
Вторичные конечные точки (8)
  • The development of total brain small vessel disease burden in MRI [Срок оценки: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.]
  • Blood flow density [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
  • Vascular perfusion area [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
  • Macular fovea retinal thickness [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
  • Retinal nerve fiber layer thickness [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
  • Resting state functional connectivity changes [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
  • White matter Integrity [Срок оценки: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.]
  • Number of Patients with cerebrovascular events, cardiovascular events, or death [Срок оценки: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]

Критерии участия

Критерии включения

  • Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis.
  • Patients aged from 30 to 60 years.
  • Sign informed consent.

Критерии исключения

  • Unable to cooperate with inspectors.
  • Known dementia.
  • Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).
  • Serious systemic illness, such as heart, liver, kidney disease or major mental illness.
  • Contraindications for imaging examination.

Exit Criteria:

  • Not meet the inclusion criteria.
  • For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
  • Any adverse or serious adverse events during the study period judged by investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Zhejiang Provincial People's Hospital — Ханчжоу

Публикации

  • Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilo PMID 37236211
  • Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.000000000000 PMID 35766027

Идентификаторы

NCT: NCT06164262 · KY2023054

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗