Primary AldosteronismPACDNCT07304674
The Association Between Primary Aldosteronism and Cognitive Dysfunction
An observational study of Primary Aldosteronism and Cognitive Dysfunction, run by Xinjiang Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Aldosteronism, Cognitive Dysfunction, Mild Cognitive Impairment (MCI)
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 31 Dec 2025to Dec 2031
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610000
peijian wang, PhD, +86-18272558112, wpjmed@aliyun.com
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
xiang xie, PhD, +86-991-4366892, xiangxie999@sina.com
Kaige Feng, +86-17828098050, fengkaigedoc@163.com
About this study
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:
- What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it?
- 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.
Read the 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.
- Medical subject headings
- Hyperaldosteronism, Cognitive Dysfunction, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Secondary outcomes (25)
Baseline Prevalence of Cognitive Impairment (MCI or Dementia) in Patients with PA
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.
Measured: Baseline
3-year cumulative incidence of cognitive progression in patients with PA
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.
Measured: Baseline, 12, 24, and 36 months.
Longitudinal Change in Global Cognitive Function
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).
Measured: Baseline, 12, 24, 36, 48, and 60 months
Change in Functional Activities Questionnaire (FAQ) total score
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.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Change in Neuropsychiatric Inventory (NPI) Total Score
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.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Office Blood Pressure Control Rate
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.
Measured: 12, 24, 36, 48, and 60 months.
24-Hour Ambulatory Blood Pressure Control Rate
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.
Measured: 12, 24, 36, 48, and 60 months.
Plasma Aldosterone Concentration (PAC)
Absolute plasma aldosterone concentration, measured in pg/mL.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Plasma Renin Concentration (PRC)
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.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Serum Potassium (K+) Level
Absolute serum potassium concentration, measured in mmol/L.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Serum Sodium (Na+) Level
Absolute serum sodium concentration, measured in mmol/L.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Low-Density Lipoprotein Cholesterol (LDL-C) Level
Fasting serum concentration of LDL-C, measured in mmol/L.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Lipoprotein(a) (Lp(a)) Level
Fasting serum concentration of Lp(a), measured in nmol/L, an independent risk factor for cardiovascular disease.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Fasting Plasma Glucose Level
Concentration of glucose in plasma after ≥8 hours of fasting, measured in mmol/L.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Glycated Hemoglobin (HbA1c) Level
The percentage of HbA1c in blood, reflecting average blood glucose over the preceding 2-3 months.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Estimated Glomerular Filtration Rate (eGFR)
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).
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Urinary Albumin-to-Creatinine Ratio (UACR)
The UACR measured from a spot urine sample and reported in mg/g, a marker of kidney damage.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Left Ventricular Mass Index (LVMI)
Left ventricular mass indexed to body surface area (g/m²), calculated from echocardiographic measurements. The key criterion for diagnosing left ventricular hypertrophy.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Left Ventricular Ejection Fraction (LVEF)
The percentage of blood ejected from the left ventricle during each contraction, measured by echocardiography.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Carotid Intima-Media Thickness (CIMT)
The mean far-wall intima-media thickness of the common carotid artery (mm), measured bilaterally by ultrasound. A marker of subclinical atherosclerosis.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Plasma NfL Concentration (Sub-study)
Concentration of plasma NfL (pg/mL), a biomarker of neuroaxonal injury, measured in a pre-defined sub-cohort.
Measured: Baseline, 12, 36, and 60 months.
White Matter Hyperintensity (WMH) Volume (Sub-study)
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.
Measured: Baseline, 12, 36, and 60 months.
Cerebral Blood Flow (Sub-study)
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).
Measured: Baseline, 12, 36, and 60 months.
Incidence of Major Adverse Cardiovascular Events (MACE)
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.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
All-cause mortality
Record of deaths from any cause during follow-up. Confirmed by medical records, family follow-up, or national death registration systems.
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start31 Dec 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
- Investigators
- Xiang Xie, PhD, Study chair, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304674
- Sponsor's protocol ID
- K202511-02
- Acronym
- PACD
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Primary Aldosteronism and Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT07304674
- Acronym / sponsor ID
- PACD / K202511-02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the prevalence of baseline cognitive impairment in PA patients and what factors are associated with it?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
25 secondary outcomes
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.
Lipoprotein(a) (Lp(a)) Level
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Fasting Plasma Glucose Level
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Glycated Hemoglobin (HbA1c) Level
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Urinary Albumin-to-Creatinine Ratio (UACR)
Time frame: 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 Ejection Fraction (LVEF)
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Carotid Intima-Media Thickness (CIMT)
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Plasma NfL Concentration (Sub-study)
Time frame: Baseline, 12, 36, and 60 months.
White Matter Hyperintensity (WMH) Volume (Sub-study)
Time frame: Baseline, 12, 36, and 60 months.
Cerebral Blood Flow (Sub-study)
Time frame: Baseline, 12, 36, and 60 months.
Incidence of Major Adverse Cardiovascular Events (MACE)
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
All-cause mortality
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiang Xie, PhD study chair
First Affiliated Hospital of Xinjiang Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism and Cognitive Dysfunction, run by Xinjiang Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Xie, PhD (+86-991-4366892, xiangxie999@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Early Cognitive Progression in Patients with PA (time frame: Baseline and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.