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Trial · NCT06219915

Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm

NCT06219915, Phase 1, Phase 2, Completed, University of Michigan; results first posted 2025-06-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm. Trials, record NCT06219915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06219915

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Placebo-Controlled Arm
NCT number
NCT06219915
Status
Completed
Phases
Phase 1, Phase 2
Enrollment
13 participants, actual
Lead sponsor
University of Michigan
Conditions
Parkinsonian Signs in Older Persons
Interventions
Carbidopa 25 mg, Carbidopa-Levodopa 25/100 mg, Placebo 1, Placebo 2
First posted
2024-01-23
Last updated
2025-06-17
Results first posted
2025-06-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAverage Gait SpeedBaseline 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.
SecondaryParkinson's Disease (PD)-Cognitive Rating Scale ScoreBaseline 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).
SecondaryMean of Number of Incorrect Responses on the Stroop Color Word Stepping TestBaseline 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.
SecondaryMean of Reaction Time During the Stroop Color Word Stepping TestBaseline 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.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAverage Gait SpeedBaseline and post-intervention (7-13 days after beginning supplement)meters per secondMEAN
SECONDARYParkinson's Disease (PD)-Cognitive Rating Scale ScoreBaseline and post-intervention (7-13 days after beginning supplement)score on a scaleMEAN
SECONDARYMean of Number of Incorrect Responses on the Stroop Color Word Stepping TestBaseline and post-intervention (7-13 days after beginning supplement)Incorrect ResponsesMEAN
SECONDARYMean of Reaction Time During the Stroop Color Word Stepping TestBaseline and post-intervention (7-13 days after beginning supplement)secondsMEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Average Gait SpeedCarbidopa Monotherapy and Carbidopa-LevodopaGait Speed at Baseline0.97Standard Deviation 0.14meters per second
Average Gait SpeedPlaceboGait Speed at Baseline0.86Standard Deviation 0.18meters per second
Average Gait SpeedCarbidopa Monotherapy and Carbidopa-LevodopaGait Speed Post-Intervention1.04Standard Deviation 0.09meters per second
Average Gait SpeedPlaceboGait Speed Post-Intervention0.95Standard Deviation 0.12meters per second
Parkinson's Disease (PD)-Cognitive Rating Scale ScoreCarbidopa Monotherapy and Carbidopa-LevodopaBaseline93.83Standard Deviation 5.91score on a scale
Parkinson's Disease (PD)-Cognitive Rating Scale ScorePlaceboBaseline89.80Standard Deviation 9.58score on a scale
Parkinson's Disease (PD)-Cognitive Rating Scale ScoreCarbidopa Monotherapy and Carbidopa-LevodopaPost-Intervention95.5Standard Deviation 8.50score on a scale
Parkinson's Disease (PD)-Cognitive Rating Scale ScorePlaceboPost-Intervention95.20Standard Deviation 13.52score on a scale
Mean of Number of Incorrect Responses on the Stroop Color Word Stepping TestCarbidopa Monotherapy and Carbidopa-LevodopaBaseline0.17Standard Deviation 0.41Incorrect Responses
Mean of Number of Incorrect Responses on the Stroop Color Word Stepping TestPlaceboBaseline0.8Standard Deviation 1.79Incorrect Responses

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCarbidopa Monotherapy and Carbidopa-Levodopa6
Overall StudySTARTEDPlacebo5
Overall StudyCOMPLETEDCarbidopa Monotherapy and Carbidopa-Levodopa6
Overall StudyCOMPLETEDPlacebo5
Overall StudyNOT COMPLETEDCarbidopa Monotherapy and Carbidopa-Levodopa0
Overall StudyNOT COMPLETEDPlacebo0

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherHeadacheGeneral disordersCarbidopa Monotherapy and Carbidopa-Levodopa16
otherHeadacheGeneral disordersPlacebo05
otherBlood pressure fluctuationsCardiac disordersCarbidopa Monotherapy and Carbidopa-Levodopa16
otherBlood pressure fluctuationsCardiac disordersPlacebo05
otherClaustrophobia during MRIPsychiatric disordersCarbidopa Monotherapy and Carbidopa-Levodopa16
otherClaustrophobia during MRIPsychiatric disordersPlacebo05
otherMild ConfusionPsychiatric disordersCarbidopa Monotherapy and Carbidopa-Levodopa06
otherMild ConfusionPsychiatric disordersPlacebo15
otherConstipationGastrointestinal disordersCarbidopa Monotherapy and Carbidopa-Levodopa06
otherConstipationGastrointestinal disordersPlacebo15

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCarbidopa Monotherapy and Carbidopa-Levodopa06
Total, all-cause mortalityPlacebo05
Total, other adverse eventsCarbidopa Monotherapy and Carbidopa-Levodopa36
Total, other adverse eventsPlacebo35
Total, serious adverse eventsCarbidopa Monotherapy and Carbidopa-Levodopa06
Total, serious adverse eventsPlacebo05

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U01AG061393Neurobiological drivers of mobility resilience: the dopaminergic systemROSANO, CATERINA; BOHNEN, NICOLAAS IDAUNIVERSITY OF PITTSBURGH AT PITTSBURGHNATIONAL INSTITUTE ON AGING2018 to 2022

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Carbidopa Monotherapy and Carbidopa-Levodopa vs Placebo: deaths from any causeTrial comparisons
Carbidopa Monotherapy and Carbidopa-Levodopa vs Placebo: serious adverse eventsTrial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Stroop Color-Word TestSecondary outcome

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06219915

GET https://conductscience.org/api/trials/v1/NCT06219915/registered