Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07234890

Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.

Led by London Health Sciences Centre Research Institute · Updated on 2026-04-17

60

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

Sponsors

L

London Health Sciences Centre Research Institute

Lead Sponsor

V

Vasomune Therapeutics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent
  • Male and non-pregnant female patients over 18 years old
  • Receiving hemodialysis for at least 3 months
  • On a thrice weekly hemodialysis schedule
Not Eligible

You will not qualify if you...

  • Receiving hemodialysis for less than 90 days
  • Contraindication to MRI
  • Severe cognitive impairment (MoCA score below 18) or diagnosed dementia
  • History of clinical stroke
  • Pregnancy, breastfeeding, or planning pregnancy
  • Intradialytic hypotension event in the past month defined as a drop in systolic blood pressure of 40 mmHg or more with symptoms requiring intervention

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

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Research Team

J

Jarrin D Penny, PhD, RN

CONTACT

K

Kathy Koyle

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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