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Идёт набор NCT07304674

The Association Between Primary Aldosteronism and Cognitive Dysfunction

— Наблюдательное Primary Aldosteronism Cognitive Dysfunction Mild Cognitive Impairment (MCI) Dementia

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Primary Aldosteronism, Cognitive Dysfunction, Mild Cognitive Impairment (MCI), Dementia. Базовые параметры: от 40 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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Обзор

The goal of this observational study is to learn about the prevalence, progression, and influencing factors of cognitive impairment in patients with primary aldosteronism (PA). The main questions it aims to answer are: 1. What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it? 2. What is the incidence of cognitive progression in PA patients within 1 and 5 years of follow-up and what factors influence this progression? Participants who are already diagnosed with PA as part of their regular medical care will be invited to join this long-term study. They will complete regular cognitive tests, medical check-ups, and questionnaires for up to 5 years. Some participants will also have optional blood tests and brain scans to help researchers understand the causes behind any cognitive changes.

Подробное описание

This is a prospective observational cohort study conducted in two tertiary hospitals. The main purposes are to investigate the prevalence and influencing factors of mild cognitive impairment (MCI) and dementia at baseline in patients with primary aldosteronism (PA), assess the incidence and influencing factors of cognitive progression within 1 and 5 years of follow-up, and compare exploratory biomarkers, such as plasma neurofilament light chain (NfL) and brain magnetic resonance imaging (MRI) measures, between PA patients with and without baseline cognitive impairment. Eligible patients will be followed up for 5 years, with regular cognitive function assessment, clinical indicator monitoring, and detection of relevant biomarkers and imaging indicators. The study aims to delineate the cognitive trajectory in PA and identify associated clinical and biological predictors.

Первичные конечные точки

  • 1-Year Early Cognitive Progression in Patients with PA [Срок оценки: Baseline and 12 months.]
  • 5-Year Cumulative Incidence of Cognitive Progression in Patients with PA [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
Вторичные конечные точки (12)
  • Baseline Prevalence of Cognitive Impairment (MCI or Dementia) in Patients with PA [Срок оценки: Baseline]
  • 3-year cumulative incidence of cognitive progression in patients with PA [Срок оценки: Baseline, 12, 24, and 36 months.]
  • Longitudinal Change in Global Cognitive Function [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months]
  • Change in Functional Activities Questionnaire (FAQ) total score [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Change in Neuropsychiatric Inventory (NPI) Total Score [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Office Blood Pressure Control Rate [Срок оценки: 12, 24, 36, 48, and 60 months.]
  • 24-Hour Ambulatory Blood Pressure Control Rate [Срок оценки: 12, 24, 36, 48, and 60 months.]
  • Plasma Aldosterone Concentration (PAC) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Plasma Renin Concentration (PRC) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Serum Potassium (K+) Level [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Serum Sodium (Na+) Level [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Low-Density Lipoprotein Cholesterol (LDL-C) Level [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]

Критерии участия

Критерии включения

  • 1\. Aged ≥ 40 years.
  • 2\. Biochemically confirmed diagnosis of Primary Aldosteronism (PA) according to contemporary guidelines (e.g., confirmed positive case detection test and confirmatory test).
  • 3\. Ability to understand and cooperate with comprehensive neuropsychological assessment.
  • 4\. Voluntary participation and provision of written informed consent.

Критерии исключения

  • 1\. Significant visual, hearing, or motor impairment that prevents completion of cognitive testing.
  • 2\. History of major neurological disorders (e.g., stroke, Parkinson's disease, intracranial tumor, severe traumatic brain injury).
  • 3\. History of major psychiatric illness, intellectual disability, or current use of antipsychotic medications.
  • 4\. Diagnosis of secondary hypertension other than PA.
  • 5\. Unwillingness to participate by the patient or their legal representative.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • The First Affiliated Hospital of Chengdu Medical College — Чэнду
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Идентификаторы

NCT: NCT07304674 · K202511-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗