Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
ConditionHemodialysis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute
About this trial
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 criteria
Qualifiers
Ability to provide informed consent
Male and non-pregnant female patients (>18 years old)
HD for ≥ 3 months
Thrice weekly HD schedule
Disqualifiers
HD <90 days
Contraindication to MRI
Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) <18 or formal diagnosis of dementia)
Previous clinical stroke
Trial design
Treatments tested in this trial
- AV-001 or Placebo Injection
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
London Health Sciences Centre Research Institute
Lead sponsor
Vasomune Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov