The Association Between Primary Aldosteronism and Cognitive Dysfunction (PACD)

January 1, 2026 updated by: Xiang Xie, Xinjiang Medical University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • The First Affiliated Hospital of Chengdu Medical College
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
1-Year Early Cognitive Progression in Patients with PA
Time Frame: 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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baseline Prevalence of Cognitive Impairment (MCI or Dementia) in Patients with PA
Time Frame: Baseline
The proportion of patients with PA who have MCI or dementia at study baseline, as adjudicated by an independent endpoint committee using the NIA-AA criteria.
Baseline
3-year cumulative incidence of cognitive progression in patients with PA
Time Frame: Baseline, 12, 24, and 36 months.
The proportion of patients who experience cognitive progression within 3 years of follow-up. Cognitive progression is defined as the same transitions and diagnostic criteria (NIA-AA) as the primary outcomes.
Baseline, 12, 24, and 36 months.
Longitudinal Change in Global Cognitive Function
Time Frame: Baseline, 12, 24, 36, 48, and 60 months
Change in global cognitive function as measured by the validated Chinese version of the Montreal Cognitive Assessment (MoCA, Beijing version). The total score ranges from 0 to 30 (higher scores indicate better cognitive function).
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.
Change in the validated Chinese version of the NPI total score (range: 0-144; higher scores indicate greater neuropsychiatric symptom burden), assessing 12 behavioral domains.
Baseline, 12, 24, 36, 48, and 60 months.
Plasma Aldosterone Concentration (PAC)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Absolute plasma aldosterone concentration, measured in pg/mL.
Baseline, 12, 24, 36, 48, and 60 months.
Plasma Renin Concentration (PRC)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
The absolute concentration of renin in plasma, measured in pg/mL. This outcome, along with aldosterone, is used to calculate the aldosterone-to-renin ratio (ARR), a key screening and diagnostic biomarker for PA.
Baseline, 12, 24, 36, 48, and 60 months.
Serum Potassium (K+) Level
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Absolute serum potassium concentration, measured in mmol/L.
Baseline, 12, 24, 36, 48, and 60 months.
Serum Sodium (Na+) Level
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Absolute serum sodium concentration, measured in mmol/L.
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.
Fasting serum concentration of LDL-C, measured in mmol/L.
Baseline, 12, 24, 36, 48, and 60 months.
Lipoprotein(a) (Lp(a)) Level
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Fasting serum concentration of Lp(a), measured in nmol/L, an independent risk factor for cardiovascular disease.
Baseline, 12, 24, 36, 48, and 60 months.
Fasting Plasma Glucose Level
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Concentration of glucose in plasma after ≥8 hours of fasting, measured in mmol/L.
Baseline, 12, 24, 36, 48, and 60 months.
Urinary Albumin-to-Creatinine Ratio (UACR)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
The UACR measured from a spot urine sample and reported in mg/g, a marker of kidney damage.
Baseline, 12, 24, 36, 48, and 60 months.
Left Ventricular Mass Index (LVMI)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Left ventricular mass indexed to body surface area (g/m²), calculated from echocardiographic measurements. The key criterion for diagnosing left ventricular hypertrophy.
Baseline, 12, 24, 36, 48, and 60 months.
Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
The percentage of blood ejected from the left ventricle during each contraction, measured by echocardiography.
Baseline, 12, 24, 36, 48, and 60 months.
Carotid Intima-Media Thickness (CIMT)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
The mean far-wall intima-media thickness of the common carotid artery (mm), measured bilaterally by ultrasound. A marker of subclinical atherosclerosis.
Baseline, 12, 24, 36, 48, and 60 months.
Cerebral Blood Flow (Sub-study)
Time Frame: Baseline, 12, 36, and 60 months.
Quantitative measurement of regional and global cerebral blood flow, obtained via arterial spin labeling (ASL) magnetic resonance imaging, and reported in milliliters per 100 grams of tissue per minute (mL/100g/min).
Baseline, 12, 36, and 60 months.
Incidence of Major Adverse Cardiovascular Events (MACE)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
The proportion of patients who experience an adjudicated MACE, a composite of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death.
Baseline, 12, 24, 36, 48, and 60 months.
All-cause mortality
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Record of deaths from any cause during follow-up. Confirmed by medical records, family follow-up, or national death registration systems.
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 the total score of the validated Chinese version of the FAQ (range 0-30; higher scores indicate greater impairment). This scale assesses instrumental activities of daily living.
Baseline, 12, 24, 36, 48, and 60 months.
Office Blood Pressure Control Rate
Time Frame: 12, 24, 36, 48, and 60 months.
The proportion of patients achieving controlled office blood pressure at each post-baseline follow-up visit. Control is defined as an average of triplicate seated measurements with systolic blood pressure (SBP) < 140 mmHg and diastolic blood pressure (DBP) < 90 mmHg.
12, 24, 36, 48, and 60 months.
24-Hour Ambulatory Blood Pressure Control Rate
Time Frame: 12, 24, 36, 48, and 60 months.
The proportion of patients achieving controlled 24-hour ambulatory blood pressure. Control is defined as a mean 24-hour SBP < 130 mmHg and DBP < 80 mmHg.
12, 24, 36, 48, and 60 months.
Glycated Hemoglobin (HbA1c) Level
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
The percentage of HbA1c in blood, reflecting average blood glucose over the preceding 2-3 months.
Baseline, 12, 24, 36, 48, and 60 months.
Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, 12, 24, 36, 48, and 60 months.
Renal function assessed by the eGFR, calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (units: mL/min/1.73m²).
Baseline, 12, 24, 36, 48, and 60 months.
Plasma NfL Concentration (Sub-study)
Time Frame: Baseline, 12, 36, and 60 months.
Concentration of plasma NfL (pg/mL), a biomarker of neuroaxonal injury, measured in a pre-defined sub-cohort.
Baseline, 12, 36, and 60 months.
White Matter Hyperintensity (WMH) Volume (Sub-study)
Time Frame: Baseline, 12, 36, and 60 months.
Total volume of white matter hyperintensities, quantified in cubic millimeters (mm³) from T2-fluid-attenuated inversion recovery (FLAIR) magnetic resonance imaging sequences. WMH volume is a quantitative marker of cerebral small vessel disease burden.
Baseline, 12, 36, and 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xinjiang Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xiang Xie, PhD, First Affiliated Hospital of Xinjiang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K202511-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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