Phase 2
N=14
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System
Parkinsonian Signs in Older Persons
Bottom Line
View on ClinicalTrials.gov: NCT04325503 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Average Gait Speed — 0.973 meters/second — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carbidopa (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Gait Speed |
0.973 | 0.015 sig |
| PRIMARY Montreal Cognitive Assessment (MoCA) |
27.44 | 0.694 |
| PRIMARY Mini Balance Evaluation Systems Test (Mini-BESTest) |
22.89 | 0.103 |
| PRIMARY Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total |
31.18 | 0.321 |
| PRIMARY Cognitive Z-score |
0.271 | 0.265 |
| PRIMARY Wechsler Adult Intelligence System Digit Symbol Substitution Test |
65.89 | 0.0270 sig |
| SECONDARY Short Activities-specific Balance Confidence Scale Score |
70.00 | 0.153 |
Summary
Walking with age becomes both slower and less 'automated', requiring more attention and brain resources. As a result, older adults have a greater risk of negative outcomes and falls. There is an urgent need to identify factors that can help compensate for these harmful factors and reduce walking impairments, as there are currently no effective treatments available. Investigators have recently discovered that ~20% of older adults maintain fast walking speed even in the presence of small blood vessel brain changes and leg problems, thus appearing to be protected against these harmful factors. The investigators work suggests that the brain dopamine (DA) system may be a source of this protective capacity. Investigators have also shown that lower levels of dopamine are associated with slow walking. Investigators will be investigating the role of dopamine on slow walking and other parkinsonian signs using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.
Eligibility Criteria
Inclusion Criteria
- Age 60 or older (M/F)
- Evidence of mild parkinsonian signs (incl. slow gait (< 1m/s))
Exclusion Criteria
- Presence of clinically significant degenerative joint disease and/or neuropathy interfering with proper assessment of the motor UPDRS exam.
- Presence of significant dementia.
- Evidence of a large vessel stroke in a clinically relevant area (cerebral cortex, basal ganglia, thalamus) or mass lesion on structural brain imaging (MRI).
- Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant.
- Severe claustrophobia precluding neuroimaging procedures.
- Hypersensitivity to the carbidopa, levodopa, and tablet components.
- Any other medical history determined by investigators to preclude safe participation.
Data sourced from ClinicalTrials.gov (NCT04325503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.