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Recruiting NCT07304674

The Association Between Primary Aldosteronism and Cognitive Dysfunction

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Aldosteronism, Cognitive Dysfunction, Mild Cognitive Impairment (MCI), Dementia. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • The First Affiliated Hospital of Chengdu Medical College — Chengdu
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Identifiers

NCT: NCT07304674 · K202511-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗