RecruitingPhase 2NCT06679374

Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease


Sponsor

Vikas Kotagal

Enrollment

102 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests varenicline — a medication commonly used to help people quit smoking — as a treatment to reduce falls in people with Parkinson's disease (PD) who have low levels of acetylcholine, a brain chemical that helps with balance and gait. Falls are a major cause of injury in PD. **You may be eligible if...** - You have a confirmed diagnosis of Parkinson's disease - Brain imaging shows you have low cholinergic activity in a specific brain region (occipital cortex) linked to fall risk - You have a history of falls or significant balance problems - You are willing to take varenicline and attend study visits **You may NOT be eligible if...** - Your cholinergic activity in the relevant brain region is not in the lowest range - You have a history of severe psychiatric conditions (e.g., psychosis, suicidal ideation) - You are currently taking cholinesterase inhibitors or other conflicting medications - You have severe kidney disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

Participants will take one pill (.5 milligrams) a day for days 1-3 and then one pill (.5 milligrams) in the morning and one pill in the evening days 4-30 and months 2-12. In month 13 participants will take one pill in the morning days 1-3. Participants will be off study drug month 13 days 4-30.

DRUGVarenicline

Participants will take one pill (.5 milligrams) a day for days 1-3 and then one pill (.5 milligrams) in the morning and one pill in the evening days 4-30 and months 2-12. In month 13 participants will take one pill in the morning days 1-3. Participants will be off study drug month 13 days 4-30.


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT06679374


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