Trial Outcomes & Findings for Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD (NCT NCT04600323)

Last Updated: 2024-12-20

Results Overview

Cognitive function will be determined using the NIH Toolbox-Cognition Battery computerized tests. The Cognitive function composite score is based on the average of the Fluid and Crystallized composites. It is derived by averaging the Fluid and Crystallized standard scores, then deriving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. The T-score has a mean of 50 in the general population and a SD of 10. Scores higher than the mean indicate better performance.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

34 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2024-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Overall Study STARTED	16	18
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=18 Participants Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months	Total n=34 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 5.9 • n=5 Participants	62.0 years STANDARD_DEVIATION 7.5 • n=7 Participants	61.3 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants
Hypertension	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Diabetes	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Bicarbonate (mEq/L)	21.8 mEq/L STANDARD_DEVIATION 1.9 • n=5 Participants	23.0 mEq/L STANDARD_DEVIATION 1.5 • n=7 Participants	22.7 mEq/L STANDARD_DEVIATION 2.3 • n=5 Participants
GFR (ml/min/1.73m2)	32.8 ml/min/1.73m2 STANDARD_DEVIATION 10.9 • n=5 Participants	36.9 ml/min/1.73m2 STANDARD_DEVIATION 16.7 • n=7 Participants	34.8 ml/min/1.73m2 STANDARD_DEVIATION 13.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=17 Participants Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Change in Cognitive Function Composite Score at 12 Months Baseline	52.3 T-score Standard Deviation 8.8	47.3 T-score Standard Deviation 8.5
Change in Cognitive Function Composite Score at 12 Months 12 months	53.5 T-score Standard Deviation 8.5	49.3 T-score Standard Deviation 11.0

PRIMARY outcome

Timeframe: baseline and 12 months

NIH Toolbox will be used to assess fluid cognition composite score. This score includes all the tests that are measuring fluid ability: Flanker, Dimensional Change, Picture sequence memory, list sorting and pattern comparison. The composite score is derived by averaging the standard scores of each of the measures. Fully Corrected T-scores are adjusted for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. A fully corrected T-score at or near 50 (population mean with standard deviation of 10) indicates ability that is average compared with others nationally and one below 40 suggests the possibility of cognitive impairment. N

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=17 Participants Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Change in Fluid Cognition Composite Score at 12 Months Baseline	52.1 T-score Standard Deviation 10.8	44.7 T-score Standard Deviation 8.7
Change in Fluid Cognition Composite Score at 12 Months 12 months	53.0 T-score Standard Deviation 9.4	46.9 T-score Standard Deviation 11.7

PRIMARY outcome

Timeframe: baseline and 12 months

NIH Toolbox will be used to assess crystallized cognition composite score. This composite score includes the picture vocabulary and reading tests. The composite score is derived by averaging the standard scores of each of the measure, and then driving standard scores based on this new distribution. Fully Corrected T-scores are adjusted for age, gender, race/ethnicity, and educational attainment. The score compares the score of the participant to those in the NIH Toolbox nationally representative normative sampling. A fully corrected T-score at or near 50 (population mean with standard deviation of 10) indicates ability that is average compared with others nationally as the mean T-score is 50 nationally. A score higher than 50 indicates better crystallized cognition.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=17 Participants Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Change in Crystallized Cognition Composite Score at 12 Months Baseline	52.8 T-score Standard Deviation 8.3	49.6 T-score Standard Deviation 8.0
Change in Crystallized Cognition Composite Score at 12 Months 12 months	53.5 T-score Standard Deviation 7.6	50.6 T-score Standard Deviation 9.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Relative cerebrovascular reactivity was calculated as % change in mean blood flow velocity of the middle cerebral artery/(hypercapnia breath-by-breath end-tidal partial pressure of CO2 (ETCO2) minus resting ETCO2).

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=17 Participants Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Change in Cerebrovascular Reactivity at 12 Months 12 months	2.7 percent change/mmHg Standard Deviation 1.3	2.5 percent change/mmHg Standard Deviation 1.1
Change in Cerebrovascular Reactivity at 12 Months Baseline	2.5 percent change/mmHg Standard Deviation 1.4	2.4 percent change/mmHg Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured using Transcranial Doppler Ultrasonography in response to a vasodilatory hypercapnic challenge.The change in mean blood flow velocity of the middle cerebral artery (MVMCA) was computed as the difference between hypercapnic MVMCA and normocapnic MVMCA

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=17 Participants Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months Baseline	26.2 percent change Standard Deviation 17.0	22.6 percent change Standard Deviation 13.1
Percent Change in Mean Blood Flow Velocity of the Middle Cerebral Artery at 12 Months 12 months	32.3 percent change Standard Deviation 21.7	25.0 percent change Standard Deviation 12.4

Adverse Events

Placebo

Serious events: 7 serious events

Other events: 6 other events

Deaths: 0 deaths

Sodium Bicarbonate

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=16 participants at risk Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=18 participants at risk Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Cardiac disorders Hospitalization	12.5% 2/16 • Number of events 2 • 12 months	16.7% 3/18 • Number of events 3 • 12 months
Infections and infestations Hospitalization	31.2% 5/16 • Number of events 5 • 12 months	16.7% 3/18 • Number of events 3 • 12 months

Other adverse events

Other adverse events
Measure	Placebo n=16 participants at risk Placebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months	Sodium Bicarbonate n=18 participants at risk Sodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day. Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
Renal and urinary disorders Dialysis initiation	0.00% 0/16 • 12 months	11.1% 2/18 • Number of events 2 • 12 months
Cardiac disorders New Lower Extremity Edema	12.5% 2/16 • Number of events 2 • 12 months	16.7% 3/18 • Number of events 3 • 12 months
Cardiac disorders Increase in antihypertensive therapy	25.0% 4/16 • Number of events 4 • 12 months	22.2% 4/18 • Number of events 4 • 12 months
Cardiac disorders Increase in diuretic therapy	0.00% 0/16 • 12 months	16.7% 3/18 • Number of events 3 • 12 months
Renal and urinary disorders High serum bicarbonate level	0.00% 0/16 • 12 months	5.6% 1/18 • Number of events 1 • 12 months

Additional Information

Dr. Jessica Kendrick

University of Colorado Denver

Phone: 3037244837

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place