Trial Outcomes & Findings for Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm (NCT NCT06219915)
NCT ID: NCT06219915
Last Updated: 2025-06-17
Results Overview
Average gait speed as measured using wearable sensors and while walking on a sensor mat. Measured in meters per second.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline and post-intervention (7-13 days after beginning supplement)
Results posted on
2025-06-17
Participant Flow
Participants were considered "enrolled" once they signed a consent form. While thirteen participants were consented and therefore enrolled, two failed their screening post-consent. Eleven were randomized and participated in the study.
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.
|
Placebo
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo 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
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm
Baseline characteristics by cohort
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=6 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.
|
Placebo
n=5 Participants
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.0 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
76.2 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
77.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-intervention (7-13 days after beginning supplement)Average gait speed as measured using wearable sensors and while walking on a sensor mat. Measured in meters per second.
Outcome measures
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=6 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.
|
Placebo
n=5 Participants
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo 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
Gait Speed at Baseline
|
0.97 meters per second
Standard Deviation 0.14
|
0.86 meters per second
Standard Deviation 0.18
|
|
Average Gait Speed
Gait Speed Post-Intervention
|
1.04 meters per second
Standard Deviation 0.09
|
0.95 meters per second
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (7-13 days after beginning supplement)Cognitive scale designed to capture impairments in cognitive function in Parkinson's disease. (Scoring: 0-134, with higher scores indicating better performance).
Outcome measures
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=6 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.
|
Placebo
n=5 Participants
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|---|
|
Parkinson's Disease (PD)-Cognitive Rating Scale Score
Baseline
|
93.83 score on a scale
Standard Deviation 5.91
|
89.80 score on a scale
Standard Deviation 9.58
|
|
Parkinson's Disease (PD)-Cognitive Rating Scale Score
Post-Intervention
|
95.5 score on a scale
Standard Deviation 8.50
|
95.20 score on a scale
Standard Deviation 13.52
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (7-13 days after beginning supplement)During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. This will be used to compare the number of incorrect responses (stepping) from pre and post intervention visits to determine if inhibitory control improves (indicated by decrease in number of incorrect responses). The test included 8 total opportunities for response.
Outcome measures
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=6 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.
|
Placebo
n=5 Participants
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|---|
|
Mean of Number of Incorrect Responses on the Stroop Color Word Stepping Test
Baseline
|
0.17 Incorrect Responses
Standard Deviation 0.41
|
0.8 Incorrect Responses
Standard Deviation 1.79
|
|
Mean of Number of Incorrect Responses on the Stroop Color Word Stepping Test
Post-Intervention
|
0.17 Incorrect Responses
Standard Deviation 0.41
|
0.4 Incorrect Responses
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline and post-intervention (7-13 days after beginning supplement)During this test, subjects make steps based on congruent (stimulus prompts the stepping response) and incongruent (stimulus prompts inhibition of the stepping response) arrows and sounds. This will be used to compare the response time between pre and post intervention to determine if reaction time improves.
Outcome measures
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=6 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.
|
Placebo
n=5 Participants
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|---|
|
Mean of Reaction Time During the Stroop Color Word Stepping Test
Baseline
|
1.84 seconds
Standard Deviation 0.08
|
2.26 seconds
Standard Deviation 0.41
|
|
Mean of Reaction Time During the Stroop Color Word Stepping Test
Post-Intervention
|
1.85 seconds
Standard Deviation 0.33
|
1.91 seconds
Standard Deviation 0.27
|
Adverse Events
Carbidopa Monotherapy and Carbidopa-Levodopa
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carbidopa Monotherapy and Carbidopa-Levodopa
n=6 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.
|
Placebo
n=5 participants at risk
Participants will begin by taking a 25mg placebo tablet three times per day (TID) for 3 days. On day four, participants will begin taking a separate placebo tablet TID in addition to the original placebo. On day seven, participants will increase to 1.5 tablets of the second placebo TID while maintaining 25mg original placebo TID. The intervention will end after ten days of supplementation.
Placebo 1: Participants will take one 25mg placebo tablet 3 times a day for 10 days.
Placebo 2: Participants will take one 100mg placebo tablet 3 times a day on days 4-6, then increase to 1.5 tablets 3 times a day on days 7-10.
|
|---|---|---|
|
General disorders
Headache
|
16.7%
1/6 • 13 days
|
0.00%
0/5 • 13 days
|
|
Cardiac disorders
Blood pressure fluctuations
|
16.7%
1/6 • 13 days
|
0.00%
0/5 • 13 days
|
|
Psychiatric disorders
Claustrophobia during MRI
|
16.7%
1/6 • 13 days
|
0.00%
0/5 • 13 days
|
|
Psychiatric disorders
Mild Confusion
|
0.00%
0/6 • 13 days
|
20.0%
1/5 • 13 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 13 days
|
20.0%
1/5 • 13 days
|
|
General disorders
Dizziness
|
16.7%
1/6 • 13 days
|
20.0%
1/5 • 13 days
|
|
General disorders
Drowsiness
|
33.3%
2/6 • 13 days
|
0.00%
0/5 • 13 days
|
|
Injury, poisoning and procedural complications
Toe injury
|
0.00%
0/6 • 13 days
|
20.0%
1/5 • 13 days
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/6 • 13 days
|
20.0%
1/5 • 13 days
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
16.7%
1/6 • 13 days
|
0.00%
0/5 • 13 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place