Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Exploratory Study to Evaluate the Neuroprotective Effects of AV-001 on Hemodialysis-induced Brain Injury Via Cerebrovascular Stabilization in Chronic Hemodialysis Patients
London Health Sciences Centre Research Institute
60 participants
Dec 16, 2025
INTERVENTIONAL
Conditions
Summary
Cognitive decline is increasingly recognized among patients receiving maintenance hemodialysis (HD). This can include trouble remembering, slower thinking or mentally feeling foggy. This research is being done to determine if a new medication (AV-001) can protect the brain from injury caused by hemodialysis by strengthening blood vessels in the brain and reducing inflammation. If successful, this research could lead to better protection for the brains of people undergoing regular dialysis, potentially reducing the risk of cognitive decline and stroke.
Eligibility
Inclusion Criteria4
- Ability to provide informed consent
- Male and non-pregnant female patients (>18 years old)
- HD for ≥ 3 months
- Thrice weekly HD schedule
Exclusion Criteria6
- 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
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Interventions
AV-001 or Placebo administered via IV bolus injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07234890