Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Hemodialysis
In brief
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.
Key facts
- Study ID
- NCT07234890
- Run by
- London Health Sciences Centre Research Institute
- People needed
- 60
- Starts
- 2025-12-16
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to provide informed consent
- Male and non-pregnant female patients (>18 years old)
- HD for ≥ 3 months
- Thrice weekly HD schedule
You may not qualify if…
- 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
Where it is running
- London Health Sciences Centre — London, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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