The Association Between Primary Aldosteronism and Cognitive Dysfunction (PACD)

Xinjiang Medical University

Status: Enrolling

Conditions: Mild Cognitive Impairment (MCI); Cognitive Dysfunction; Primary Aldosteronism; Dementia

Study type: Observational

Funder types: Other

Identifiers

NCT07304674

K202511-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.