Neurobiological Drivers of Mobility Resilience: The Dopaminergic System
NCT04325503, Phase 1, Phase 2, Completed, University of Michigan; results first posted 2023-09-28
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neurobiological Drivers of Mobility Resilience: The Dopaminergic System | ClinicalTrials.gov |
| NCT number | NCT04325503 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 14 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of Michigan | ClinicalTrials.gov |
| Conditions | Parkinsonian Signs in Older Persons | ClinicalTrials.gov |
| Interventions | carbidopa | ClinicalTrials.gov |
| First posted | 2020-03-27 | ClinicalTrials.gov |
| Last updated | 2024-04-04 | ClinicalTrials.gov |
| Results first posted | 2023-09-28 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Average Gait Speed | 7-13 days after beginning treatment. | Average gait speed as measured using wearable sensors worn during walking tasks. Gait speed is measured in meters per second. | ClinicalTrials.gov |
| Primary | Montreal Cognitive Assessment (MoCA) | 7-13 days after beginning treatment | Cognitive assessment used to evaluate individuals for mild cognitive impairment. Scores range from 0-30. Higher scores indicate better performance. | ClinicalTrials.gov |
| Primary | Mini Balance Evaluation Systems Test (Mini-BESTest) | 7-13 days after beginning treatment | The mini-BESTest is a 14-item evaluation of dynamic balance and postural control. It is scored from 0-28, with higher scores indicating better performance. | ClinicalTrials.gov |
| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total | 7-13 days after beginning treatment | MDS-UPDRS part III is the motor examination portion of the UPDRS evaluation. Scores range from 0-132, with higher scores indicating greater severity of motor symptoms. | ClinicalTrials.gov |
| Primary | Cognitive Z-score | 7-13 days after beginning treatment | Composite variable calculated based on the Stroop Color Word Interference test I-IV (assessment of attention) and Delis-Kaplan Executive Function System Trail Making test I-V (assessment of executive function and working memory), adjusted based on normative data for older adults. A z-score of 0 represents the control population mean. Scores above the mean indicate better performance, while scores below the mean indicate poorer performance. | ClinicalTrials.gov |
| Primary | Wechsler Adult Intelligence System Digit Symbol Substitution Test | 7-13 days after beginning treatment | Evaluation of cognitive functioning in which a participant is given a key of numbers 1-9, each paired with a unique symbol. Below the key, is a series of random numbers which they participant must fill in the corresponding symbol for. They have 120 seconds to complete the task. Participants receive one point for each correct symbol written. Score range from 0-133. | ClinicalTrials.gov |
| Secondary | Short Activities-specific Balance Confidence Scale Score | 7-13 days after beginning treatment | Participants rate their level of confidence in doing specific activities without losing their balance as a percentage, with 0% indicating they are certain they would lose their balance and 100% indicating that they are certain they can complete the task without losing their balance. Scores on these 6 questions are averaged to determine total sABC score. Scores range from 0-100, with higher scores indicating greater balance confidence. | ClinicalTrials.gov |
Outcomes 7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Average Gait Speed | 7-13 days after beginning treatment. | Gait speed data was missing for one participant due to software error. | meters/second | MEAN | ClinicalTrials.gov |
| PRIMARY | Montreal Cognitive Assessment (MoCA) | 7-13 days after beginning treatment | Two participants did not complete the MoCA during the follow-up visit due to time constraints. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Mini Balance Evaluation Systems Test (Mini-BESTest) | 7-13 days after beginning treatment | Testing was not completed for two participants due to time constraints. | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total | 7-13 days after beginning treatment | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Cognitive Z-score | 7-13 days after beginning treatment | Data was not collected for 3 participants (one participant did not complete Stroop Color Word Interference tests due to language barrier. One participant did not complete cognitive assessments due to poor vision interfering with test-taking ability. One participant did not complete cognitive testing due to time constraints). | Z-score | MEAN | ClinicalTrials.gov |
| PRIMARY | Wechsler Adult Intelligence System Digit Symbol Substitution Test | 7-13 days after beginning treatment | Two participants did not complete testing due to time constraints | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Short Activities-specific Balance Confidence Scale Score | 7-13 days after beginning treatment | score on a scale | MEDIAN | ClinicalTrials.gov |
Results by group 7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Average Gait Speed | Carbidopa and Carbidopa-Levodopa Treatment | 0.973 | Standard Deviation 0.123 | meters/second | ClinicalTrials.gov | |
| Montreal Cognitive Assessment (MoCA) | Carbidopa and Carbidopa-Levodopa Treatment | 27.44 | Standard Deviation 1.59 | score on a scale | ClinicalTrials.gov | |
| Mini Balance Evaluation Systems Test (Mini-BESTest) | Carbidopa and Carbidopa-Levodopa Treatment | 22.89 | Standard Deviation 3.951 | score on a scale | ClinicalTrials.gov | |
| Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total | Carbidopa and Carbidopa-Levodopa Treatment | 31.18 | Standard Deviation 10.998 | units on a scale | ClinicalTrials.gov | |
| Cognitive Z-score | Carbidopa and Carbidopa-Levodopa Treatment | 0.271 | Standard Deviation 0.524 | Z-score | ClinicalTrials.gov | |
| Wechsler Adult Intelligence System Digit Symbol Substitution Test | Carbidopa and Carbidopa-Levodopa Treatment | 65.89 | Standard Deviation 20.829 | score on a scale | ClinicalTrials.gov | |
| Short Activities-specific Balance Confidence Scale Score | Carbidopa and Carbidopa-Levodopa Treatment | 70.00 | Full Range 21.67 to 93.3 | score on a scale | ClinicalTrials.gov |
Participant flow 3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Carbidopa and Carbidopa-Levodopa Treatment | 14 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Carbidopa and Carbidopa-Levodopa Treatment | 11 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Carbidopa and Carbidopa-Levodopa Treatment | 3 | ClinicalTrials.gov |
Adverse events 7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Carbidopa and Carbidopa-Levodopa Treatment | 4 | 14 | 4 | ClinicalTrials.gov |
| other | Vivid dreams | General disorders | Carbidopa and Carbidopa-Levodopa Treatment | 2 | 14 | 2 | ClinicalTrials.gov |
| other | Mild Changes to Bowel Movement | Gastrointestinal disorders | Carbidopa and Carbidopa-Levodopa Treatment | 1 | 14 | 1 | ClinicalTrials.gov |
| other | Mild Nasal Congestion | General disorders | Carbidopa and Carbidopa-Levodopa Treatment | 2 | 14 | 2 | ClinicalTrials.gov |
| other | Anxiety | Psychiatric disorders | Carbidopa and Carbidopa-Levodopa Treatment | 1 | 14 | 2 | ClinicalTrials.gov |
| other | Headache | General disorders | Carbidopa and Carbidopa-Levodopa Treatment | 2 | 14 | 2 | ClinicalTrials.gov |
| other | Change in Blood Glucose Level | Metabolism and nutrition disorders | Carbidopa and Carbidopa-Levodopa Treatment | 1 | 14 | 1 | ClinicalTrials.gov |
Adverse event totals 3
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Carbidopa and Carbidopa-Levodopa Treatment | 0 | 14 | ClinicalTrials.gov |
| Total, other adverse events | Carbidopa and Carbidopa-Levodopa Treatment | 8 | 14 | ClinicalTrials.gov |
| Total, serious adverse events | Carbidopa and Carbidopa-Levodopa Treatment | 0 | 14 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01AG061393 | Neurobiological drivers of mobility resilience: the dopaminergic system | ROSANO, CATERINA; BOHNEN, NICOLAAS IDA | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE ON AGING | 2018 to 2022 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)