The Association Between Primary Aldosteronism and Cognitive Dysfunction (NCT07304674) | Clinical Trial Compass
RecruitingNot Applicable
The Association Between Primary Aldosteronism and Cognitive Dysfunction
China1,000 participantsStarted 2025-12-31
Plain-language 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. 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-Year Early Cognitive Progression in Patients with PA
Timeframe: Baseline and 12 months.
2
5-Year Cumulative Incidence of Cognitive Progression in Patients with PA
Timeframe: Baseline, 12, 24, 36, 48, and 60 months.