The Association Between Primary Aldosteronism and Cognitive Dysfunction

NCT07304674 | Recruiting DMC

• 1 other identifier: K202511-02
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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. 1.What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it?
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 1-Year Early Cognitive Progression in Patients with PA

  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.

  Baseline and 12 months.

• 5-Year Cumulative Incidence of Cognitive Progression in Patients with PA

  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.

  Baseline, 12, 24, 36, 48, and 60 months.

Secondary Outcomes (25)

• Baseline Prevalence of Cognitive Impairment (MCI or Dementia) in Patients with PA

  Baseline

• 3-year cumulative incidence of cognitive progression in patients with PA

  Baseline, 12, 24, and 36 months.

• Longitudinal Change in Global Cognitive Function

  Baseline, 12, 24, 36, 48, and 60 months

• Change in Functional Activities Questionnaire (FAQ) total score

  Baseline, 12, 24, 36, 48, and 60 months.

• Change in Neuropsychiatric Inventory (NPI) Total Score

  Baseline, 12, 24, 36, 48, and 60 months.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will establish a prospective, two-center cohort of primary aldosteronism (PA). Designed to capture the full baseline spectrum of cognitive function, the cohort aims to systematically determine the incidence and progression of cognitive impairment and identify its clinical and biochemical predictors.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xinjiang Medical University: lead

Study Sites (2)

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610000, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Xiang Xie, PhD

  First Affiliated Hospital of Xinjiang Medical University

  STUDY CHAIR

Central Study Contacts

Xiang Xie, PhD

CONTACT

+86-991-4366892; xiangxie999@sina.com

Kaige Feng

CONTACT

+86-17828098050; fengkaigedoc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 26, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)