Early Phase 1
N=34
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
Metabolic Acidosis · Chronic Kidney Disease · Cognitive Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT04600323 ↗Enrolled (actual)
34
Serious AEs
38.2%
Results posted
Dec 2024
Primary outcome: Primary: Change in Cognitive Function Composite Score at 12 Months — 52.3; 47.3; 53.5; 49.3 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Sodium Bicarbonate Tablets (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cognitive Function Composite Score at 12 Months |
52.3; 47.3; 53.5; 49.3 | — |
| PRIMARY Change in Fluid Cognition Composite Score at 12 Months |
52.1; 44.7; 53.0; 46.9 | — |
| PRIMARY Change in Crystallized Cognition Composite Score at 12 Months |
52.8; 49.6; 53.5; 50.6 | — |
| SECONDARY Change in Cerebrovascular Reactivity at 12 Months |
2.5; 2.4; 2.7; 2.5 | — |
| SECONDARY Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months |
26.2; 22.6; 32.3; 25.0 | — |
Summary
This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.
Eligibility Criteria
Inclusion Criteria
- Age 50-75 years old
- Serum bicarbonate 16-22 mEq/L on 2 separate measurements (at least 1 day apart)
- CKD stage 3b or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
- Blood pressure 24
- No history of stroke
- No history of dementia
- No history of neurologic disease
- Able to provide consent
Exclusion Criteria:• Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
- Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
- Uncontrolled hypertension
- Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening
- New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
- Factors judged to limit adherence to interventions
- Anticipated initiation of dialysis or kidney transplantation within 12 months
- Current participation in another research study
- Pregnancy or planning to become pregnant or currently breastfeeding
- Chronic use of supplemental oxygen
Data sourced from ClinicalTrials.gov (NCT04600323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.