RecruitingParkinson Disease
Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease
Eligible age
45+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
This trial aims to test whether one year of Varenicline, when compared to placebo, can reduce fall risk and show improvement in the ability to multitask while walking. Participants that are eligible after screening for the study will be randomized to receive Varenicline or placebo. Along with the study medication participants will have visits (over the phone and in person), various tests and imaging, questionnaires, and laboratory collections.
Sponsor: Vikas Kotagal
You may qualify if…
- ✓ Participants with a PD diagnosis based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease at the time of baseline screening/enrollment visit
- ✓ Participants with occipital association cortex cholinergic denervation in the lowest tertile of the normal range on F-fluoroethoxybenzovesamicol (FEOBV) Positron Emission Tomography (PET)
- ✓ Participants with legally authorized representatives (LARs) able to co-sign documented informed consent or participants that have capacity to provide informed consent upon study enrollment as ascertained by the study-specific University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- ✓ Mild Cognitive Impairment consistent with Parkinson disease Mild Cognitive Impairment (PD-MCI)
You may not qualify if…
- ✕ Atypical Parkinsonian conditions other than Parkinson disease (PD)
- ✕ Participants initially on certain dopamine blocking drugs (per protocol), specific anticholinergic drugs (trihexyphenidyl, benztropine), or specific cholinesterase inhibitor drugs (per protocol) at the in-person screening visit
- ✕ Modified Hoehn and Yahr score of 4.0 or greater at the in-person screening visit
- ✕ Current or previous (within last 6 months of in-person screening visit) use of any product or medication containing nicotinic agents, including use of tobacco products such as cigarettes, cigars, pipes, chewing tobacco, etc., e-cigarettes, over the counter (OTC) nicotine patches, chewing gum containing nicotine, or varenicline
- ✕ Evidence of a stroke with both cortical and subcortical involvement or occipital lobe mass lesion on structural magnetic brain imaging (MRI) obtained at the in-person screening visit that would preclude co-registration and analysis of FEOBV PET data
- ✕ Participants where 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 MRI or PET imaging
- ✕ Participants limited by participation in research procedures involving ionizing radiation
Where it's recruiting
Michigan
Ann Arbor
Source: ClinicalTrials.gov · NCT06679374 · last updated 2026-03-31