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Alkalinizing Agent
Sodium Bicarbonate Tablets for Cognitive Impairment
Phase < 1
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Summary
This trial is testing whether sodium bicarbonate can improve cognitive and cerebrovascular function in patients with CKD stage 3b-4 who have metabolic acidosis.
Eligible Conditions
- Cognitive Impairment
- Acidosis
- Chronic Kidney Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Cognitive Function at 12 months
Change in Cognitive Function composite score at 12 months
Change in Crystallized cognition composite score at 12 months
+1 moreSecondary study objectives
Change in Cerebrovascular hemodynamics at 12 months
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sodium bicarbonateExperimental Treatment1 Intervention
Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day.
Group II: PlaceboPlacebo Group1 Intervention
Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Bicarbonate Tablets
2021
Completed Early Phase 1
~40
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,322 Total Patients Enrolled
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