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Clinical Trials in China / NCT07304674
Recruiting Observational

The Association Between Primary Aldosteronism and Cognitive Dysfunction

NCT07304674 · tracked via the Priya Life Science China tracker
Sponsor
Xinjiang Medical University
Phase
Observational
Started
2025-12-31
Last updated
2026-01-05

Condition(s) studied

Primary AldosteronismCognitive DysfunctionMild Cognitive Impairment (MCI)Dementia

Study summary

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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • 1-Year Early Cognitive Progression in Patients with PA — Baseline and 12 months.
    Defined as the proportion of PA patients who experience cognitive progression within 1 year of follow-up. Cognitive progression includes three transitions: 1) Normal cognition → MCI; 2) Normal cognition → Dementia; 3) MCI → Dementia.The diagnostic criteria for MCI and dementia are based on the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (for MCI and dementia). All events are adjudicated by an independent endpoint committee.
  • 5-Year Cumulative Incidence of Cognitive Progression in Patients with PA — Baseline, 12, 24, 36, 48, and 60 months.
    Defined as the proportion of PA patients who experience cognitive progression within 5 years of follow-up. Cognitive progression follows the same transitions and diagnostic criteria as the 1-year primary outcome (NIA-AA criteria). All events are adjudicated by an independent endpoint committee.

Trial sites (2)

FacilityCityRegionStatus
The First Affiliated Hospital of Chengdu Medical College Chengdu Sichuan Recruiting
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Recruiting

More Xinjiang Medical University trials in China

Precision Subtyping and Prognostic Study of Heart Failure Based on Multi-Omics Integration and Clinical Indicators: A Prospective Single-Center Cohort Study Starting soon
Primary Aldosteronism: Superselective Embolization vs. Laparoscopic Endocrine Curative Therapy Recruiting
Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA) Recruiting
Clinical Outcomes of Cardiovascular Disease Recruiting
Prognosis of Primary Aldosteronism: A Prospective Cohort Study Recruiting

Other trials for the same condition

A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism Active, not recruiting
Effect of Intranasal Negative Pressure Therapy on Cognitive Function in Patients With Mild Cognitive Impairment and Obstructive Sleep Apnea Starting soon
Fuzhou Aging Brain Health Initiative Recruiting
The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment Recruiting
A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07304674 on ClinicalTrials.gov ↗ ← All trials in China