The Association Between Primary Aldosteronism and Cognitive Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorXinjiang Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.2
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.Secondary outcomes
1
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
Baseline2
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.3
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 months4
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.Sponsors and contacts
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Source ClinicalTrials.gov