Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05374005
Eligibility Criteria:
Inclusion Criteria:
* Chinese ethnicity,
* age between 55 and 80-year-old, and
* a primary language of Cantonese.
* Extra inclusion criteria for CSVD group:
1. Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;
2. Modified Functional Ambulation Classification 5 or above;
3. Montreal Cognitive Assessment (MoCA) score \< 25;
Exclusion Criteria:
* Hypernatremia (Na \>146mmol/L) or hyponatremia (Na \<134 mmol/L) from screening blood test;
* With sodium supplement;
* Renal failure (stage 4 \& 5) with glomerular filtration rate \< 29;
* performed cardiac surgery or neurosurgery, with cardiac failure;
* Had major psychiatric diseases
* Contraindications for MRI.
* Dementia or MoCA score lower than 2nd percentile of the age and education adjusted cutoff ;
* Cerebral white matter changes unrelated to neurodegenerative, e.g. CADASIL, X-linked adrenoleukodystrophy, metabolic diseases, multiple sclerosis, etc.\|
* Contraindication to proposed imaging, e.g. chronic kidney disease (KDNIGO) stage 4 or above, acute kidney injury, hypersensitivity to gadolinium-based contrast, non-MRI conditional implants or prosthesis
* Medical condition that would not allow the patient to adhere to the protocol or complete the study.;
* Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.);
* Pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
80 Years
Study:
NCT05374005
Study Brief:
Protocol Section:
NCT05374005