Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
Actively Recruiting
About This Study
This Phase 2 exploratory study evaluates the neuroprotective effects of AV-001 in patients undergoing maintenance hemodialysis. Investigators aim to determine if AV-001 stabilizes the cerebrovascular endothelium and reduces inflammation to mitigate hemodialysis-induced brain injury. Participants are randomized to receive either a low dose of AV-001, a high dose of AV-001, or a placebo administered 60 minutes prior to three consecutive hemodialysis sessions. Clinical outcomes are assessed through serial cognitive testing, vascular ultrasound, and MRI to monitor structural and functional neurological changes.
Who Can Participate?
✓ Inclusion Criteria
- •Ability to provide informed consent
- •Male and non-pregnant female patients (>18 years old)
- •HD for ≥ 3 months
- •Thrice weekly HD schedule
✗ Exclusion Criteria
- •HD <90 days
- •Contraindication to MRI
- •Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) <18 or formal diagnosis of dementia)
- •Previous clinical stroke
- •Pregnancy, breastfeeding, or intending pregnancy
- •Intradialytic hypotension event (defined as: drop in SBP ≥40mmHg + symptoms + intervention) in previous month as evidenced by HD record