Status:
RECRUITING
The Impact of Excessive Dietary Sodium on Brain Health
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Cerebral Small Vessel Disease
Eligibility:
All Genders
55-80 years
Brief Summary
Sporadic cerebral small vessel disease (CSVD) is not only the most common subtype of vascular dementia, in recent multi-center study showed that sporadic CSVD harbors in a third of Alzheimer's disease...
Detailed Description
This study hypothesis that high dietary sodium is associated with CSVD-related neuroimaging measures such as reduced white matter hyperintensities, total brain volume, and white matter structural inte...
Eligibility Criteria
Inclusion
- Chinese ethnicity,
- age between 55 and 80-year-old, and
- a primary language of Cantonese.
- Extra inclusion criteria for CSVD group:
- Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;
- Modified Functional Ambulation Classification 5 or above;
- Montreal Cognitive Assessment (MoCA) score \< 25;
Exclusion
- 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.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05374005
Start Date
June 22 2022
End Date
October 30 2025
Last Update
February 15 2024
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, N.T., Hong Kong, 00000