Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
Recruiting
Phase 2
Interventional Study
Hemodialysis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Health Services Research
- Participants needed
- 60 (estimated)
- Sponsor
- London Health Sciences Centre Research Institute · Other
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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, thi…
Trial Locations
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Eligibility Criteria
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 …
Contacts