Status:
COMPLETED
Neurobiological Drivers of Mobility Resilience: The Dopaminergic System - Supplemental Open-Label Arm
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Parkinsonian Signs in Older Persons
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief 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 urgen...
Detailed Description
Walking with age becomes both slower and less 'automated', requiring more attention and prefrontal resources. As a result, older adults have a greater risk of adverse mobility outcomes and falls. Walk...
Eligibility Criteria
Inclusion
- Age 60 or older (M/F)
- Evidence of mild parkinsonian signs (incl. slow gait (\<1m/s))
Exclusion
- Evidence of prior established diagnosis and/or treatment for PD.
- Presence of clinically significant degenerative joint disease and/or neuropathy interfering with proper assessment of the motor exam.
- Presence of significant dementia.
- History of stroke with residual clinical deficit interfering with walking.
- For optional MR imaging only: 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.
- For optional brain imaging only: Severe claustrophobia precluding neuroimaging procedures.
- Participants that have been on monoamine oxidase inhibitors (MAOIs) within 2 weeks prior to starting study.
- Inability to stand or walk without an assistive device
- Hypersensitivity to the carbidopa, levodopa, and tablet components.
- History of myocardial infarction (MI) with residual arterial, nodal or ventricular arrhythmia
- History of peptic ulcer
- Chronic wide angle glaucoma
- Narrow angle glaucoma
- Major psychotic disorder
- Severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease
- Subjects on dopamine D2 receptor antagonists, dopamine depleting agents, and metoclopramide.
- Any other medical history determined by investigators to preclude safe participation.
Key Trial Info
Start Date :
October 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06587217
Start Date
October 29 2024
End Date
April 3 2025
Last Update
December 10 2025
Active Locations (2)
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1
Domino's Farms
Ann Arbor, Michigan, United States, 48105
2
University Hospital
Ann Arbor, Michigan, United States, 48109