NCT Number: NCT07234890
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
London, Ontario, N6A 5W9, Canada
Location status: Recruiting
Christopher McIntyre, MBBS DM
PRINCIPAL_INVESTIGATOR
Jarrin Penny, PhD, RN
CONTACT
519-685-8500 ext. x 58765
Kathy Koyle
CONTACT
519-685-8500 ext. x 56214
Hemodialysis provides life-sustaining treatment for many chronic kidney disease patients around the world. Moderate to severe cognitive impairment is very common in HD patients with up to 70% being affected who are ≥ 55 years of age and ~ 10% in those between 21-39 years of age. Significant cognitive impairment is evident within 6 months of starting HD.
This study is a phase 2 exploratory study in patients receiving hemodialysis treatments. Investigators will recruit 60 patients from the renal program at the London Health Sciences Centre.
Study participants will receive AV-001 (low or high dose) or placebo 60 minutes prior to HD initiation at 3 HD treatment sessions within 1 week (Monday, Wednesday and Friday)
Study participants will also undergo:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AV-001 or Placebo administered via IV bolus injection.
Time frame: Before and after dialysis on study visit day 3.
We will assess brain structure using MRI, allowing accurate detailed study of brain WM structural integrity.
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood Samples (S-100β) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)
Blood samples (transthyretin) will be collected Pre-HD, Peak HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood Samples (TNF-a) will be collected Pre-HD, Peak-HD and Post HD for analysis
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood samples (IL-6) will be collected Pre-HD, Peak-HD and Post HD for analysis
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood Samples (serum lipopolysaccharide) will be collected Pre-HD, Peak-HD and Post HD for analysis
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood Samples (complete blood count) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood Samples (urea) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Blood Samples (electrolytes) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)
Dialysate composition (sodium, potassium, calcium, magnesium, glucose) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study visit Day 1 to Study Visit Day 3 (over a 1-week period)
Blood Samples (clot-troponin T and C-reactive protein) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
AV-001 specific circulatory biomarkers (soluble Tie2, CXCL10, MCP-1, Angiopoietin-1, Angiopoietin-2) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)
The Montreal Cognitive Assessment (MoCA) is validated and highly sensitive for the detection of mild cognitive impairment and measures short term memory; visuospatial abilities; executive function; attention; concentration and working memory; language; and orientation to time and place.
Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)
The Trailsmaking 'A' Test is sensitive to various neurological impairments and provide information on visual search, scanning, speed of processing, mental flexibility and executive functions.
The patient is asked to connect numbers 1 through 25 as quickly as possible.
Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)
The Trailsmaking 'B' Test is sensitive to various neurological impairments and provide information on visual search, scanning, speed of processing, mental flexibility and executive functions. Patients are asked to alternate numbers and letters which requires thinking flexibility and mental shifting.
Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)
Creyos encompass assessments of short-term memory, reasoning, attention and verbal ability. Creyos is an online platform and will be completed on a study designated tablet.
Contact information is provided by the study sponsor or research team.
London Health Sciences Centre Research Institute
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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