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Recruiting Phase 2 NCT06679374

Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease

Trial Parameters

Condition Parkinson Disease
Sponsor Vikas Kotagal
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 102
Sex ALL
Min Age 45 Years
Max Age N/A
Start Date 2025-04-09
Completion 2027-01
Interventions
PlaceboVarenicline

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * Atypical Parkinsonian conditions other than Parkinson disease (PD) * Participants initially on certain dopamine blocking drugs (per protocol), specific anticholinergic drugs (trihe

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