Trial Outcomes & Findings for Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Supplemental Open-Label Arm (NCT NCT06587217)
NCT ID: NCT06587217
Last Updated: 2026-04-14
Results Overview
Average gait speed as measured using wearable sensors and while walking on a sensor mat. Participants rose from a seated position and then walked on a flat surface toward some cones on the floor. After reaching the cones, they then turned and returned to their starting position and sat down. The whole distance walked was 8.5 meters. Gait speed is measured in meters per second.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
At baseline, day 7, and day 13
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
Participants will begin by taking 25mg of Carbidopa monotherapy three times per day (TID) for 3 days. On day four, participants will begin taking 1 tablet of Carbidopa-Levodopa (25/100mg) TID in addition to the Carbidopa monotherapy. On day seven, participants will increase to 1.5 tablets of Carbidopa-Levodopa (25/100mg) TID while maintaining 25mg Carbidopa monotherapy TID. The intervention will end after ten days of supplementation.
Carbidopa 25 mg: Participants will take one 25mg Carbidopa tablet 3 times a day for 10 days.
Carbidopa-Levodopa 25/100 mg: Participants will take one 25/100mg carbidopa-levodopa tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
Participants will begin by taking 25mg of Carbidopa monotherapy three times per day (TID) for 3 days. On day four, participants will begin taking 1 tablet of Carbidopa-Levodopa (25/100mg) TID in addition to the Carbidopa monotherapy. On day seven, participants will increase to 1.5 tablets of Carbidopa-Levodopa (25/100mg) TID while maintaining 25mg Carbidopa monotherapy TID. The intervention will end after ten days of supplementation.
Carbidopa 25 mg: Participants will take one 25mg Carbidopa tablet 3 times a day for 10 days.
Carbidopa-Levodopa 25/100 mg: Participants will take one 25/100mg carbidopa-levodopa tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Supplemental Open-Label Arm
Baseline characteristics by cohort
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=5 Participants
Participants will begin by taking 25mg of Carbidopa monotherapy three times per day (TID) for 3 days. On day four, participants will begin taking 1 tablet of Carbidopa-Levodopa (25/100mg) TID in addition to the Carbidopa monotherapy. On day seven, participants will increase to 1.5 tablets of Carbidopa-Levodopa (25/100mg) TID while maintaining 25mg Carbidopa monotherapy TID. The intervention will end after ten days of supplementation.
Carbidopa 25 mg: Participants will take one 25mg Carbidopa tablet 3 times a day for 10 days.
Carbidopa-Levodopa 25/100 mg: Participants will take one 25/100mg carbidopa-levodopa tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|
|
Age, Continuous
|
77.8 years
STANDARD_DEVIATION 7.60 • n=193 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: At baseline, day 7, and day 13Population: One participant withdrew from the study prior to completing the 13 day gait speed test. One participant's 7 day gait speed test is missing due to sensor failure.
Average gait speed as measured using wearable sensors and while walking on a sensor mat. Participants rose from a seated position and then walked on a flat surface toward some cones on the floor. After reaching the cones, they then turned and returned to their starting position and sat down. The whole distance walked was 8.5 meters. Gait speed is measured in meters per second.
Outcome measures
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=5 Participants
Participants will begin by taking 25mg of Carbidopa monotherapy three times per day (TID) for 3 days. On day four, participants will begin taking 1 tablet of Carbidopa-Levodopa (25/100mg) TID in addition to the Carbidopa monotherapy. On day seven, participants will increase to 1.5 tablets of Carbidopa-Levodopa (25/100mg) TID while maintaining 25mg Carbidopa monotherapy TID. The intervention will end after ten days of supplementation.
Carbidopa 25 mg: Participants will take one 25mg Carbidopa tablet 3 times a day for 10 days.
Carbidopa-Levodopa 25/100 mg: Participants will take one 25/100mg carbidopa-levodopa tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|
|
Average Gait Speed
Baseline
|
0.81 meters per second
Standard Deviation 0.05
|
|
Average Gait Speed
Day 7
|
0.86 meters per second
Standard Deviation 0.05
|
|
Average Gait Speed
Day 13
|
0.86 meters per second
Standard Deviation 0.05
|
Adverse Events
Carbidopa Monotherapy and Carbidopa-Levodopa
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=5 participants at risk
Participants will begin by taking 25mg of Carbidopa monotherapy three times per day (TID) for 3 days. On day four, participants will begin taking 1 tablet of Carbidopa-Levodopa (25/100mg) TID in addition to the Carbidopa monotherapy. On day seven, participants will increase to 1.5 tablets of Carbidopa-Levodopa (25/100mg) TID while maintaining 25mg Carbidopa monotherapy TID. The intervention will end after ten days of supplementation.
Carbidopa 25 mg: Participants will take one 25mg Carbidopa tablet 3 times a day for 10 days.
Carbidopa-Levodopa 25/100 mg: Participants will take one 25/100mg carbidopa-levodopa tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • 13 days
|
|
General disorders
Sleepiness
|
60.0%
3/5 • 13 days
|
|
General disorders
Headache
|
20.0%
1/5 • 13 days
|
|
General disorders
Dizziness
|
20.0%
1/5 • 13 days
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
20.0%
1/5 • 13 days
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
1/5 • 13 days
|
|
Vascular disorders
Erectile dysfunction symptoms
|
20.0%
1/5 • 13 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place