An observational study in Primary Aldosteronism, Cognitive Dysfunction and Mild Cognitive Impairment (MCI), sponsored by Xinjiang Medical University. Recruiting at 2 sites in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Xinjiang Medical University · Observational
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:
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.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 103 observational studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Xinjiang Medical University is the lead sponsor of 21 studies on the registry; 11 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12, 24, 36, 48, and 60 months.
Plasma Aldosterone Concentration (PAC)
Absolute plasma aldosterone concentration, measured in pg/mL.
Time frame: 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.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Serum Potassium (K+) Level
Absolute serum potassium concentration, measured in mmol/L.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Serum Sodium (Na+) Level
Absolute serum sodium concentration, measured in mmol/L.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
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Xinjiang Medical University