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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Parkinsonian Signs in Older Persons

In brief

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 in this double-blinded, placebo-controlled study using detailed clinical assessment, assessment of dopamine activity, and clinical interventions.

Key facts

Study ID

NCT06219915

Run by

University of Michigan

People needed

13

Starts

2024-03-15

Expected to finish

2024-05-30

Last updated by the study team

2025-06-17

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 60 or older (M/F)
• Evidence of mild parkinsonian signs (incl. slow gait (<1m/s))

You may not qualify if…

• 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.

Where it is running

• Domino's Farms — Ann Arbor, Michigan, United States
• University Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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