Primary aldosteronism and thinking/memory problems
The Association Between Primary Aldosteronism and Cognitive Dysfunction
This study will see if people aged 40 and older with primary aldosteronism develop memory and thinking problems over 1 to 5 years and which factors influence those changes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Xinjiang Medical University Academic / other |
| Locations | 2 sites (Chengdu, Sichuan and 1 other locations) |
| Trial ID | NCT07304674 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort follows adults with confirmed primary aldosteronism at two tertiary hospitals for up to five years. Participants complete regular standardized cognitive tests, clinical assessments, and questionnaires, with optional blood tests (including plasma neurofilament light chain) and brain MRI for some individuals. The study will determine baseline prevalence of mild cognitive impairment and dementia and track incidence of cognitive progression at 1 and 5 years while analyzing clinical and biological predictors. Researchers will compare biomarker and imaging measures between PA patients with and without baseline cognitive impairment to map cognitive trajectories and potential mechanisms.
Who should consider this trial
Good fit: Adults aged 40 or older with a biochemically confirmed diagnosis of primary aldosteronism who can complete neuropsychological testing and provide informed consent are ideal candidates.
Not a fit: Patients with major neurological or psychiatric disorders, severe sensory or motor impairments, secondary hypertension other than PA, or those unwilling or unable to consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians identify which PA patients are at higher risk for cognitive decline so they can monitor and intervene earlier.
How similar studies have performed: Prior studies have suggested cognitive changes in PA and shown promise for biomarkers like plasma NfL, but long-term prospective cohort data comparing imaging and biomarkers in PA are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chengdu, Sichuan and 1 other locations
- The First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (Recruiting)
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
Study contacts
- Study coordinator: Xiang Xie, PhD
- Email: xiangxie999@sina.com
- Phone: +86-991-4366892
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.