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Reducing Falls With Varenicline in Parkinson Disease

This study is testing if a medication called Varenicline can help reduce the risk of falls and improve your ability to multitask while walking if you have Parkinson's disease. Researchers will compare Varenicline to a placebo (an inactive pill) over 12 months. To join, you must have a Parkinson's diagnosis and specific brain imaging results showing a certain level of cholinergic denervation (a type of nerve damage). The study aims to see if Varenicline leads to less decline in walking performance while multitasking and if it reduces the risk of falls. The current status of this study is unclear, and it plans to enroll 102 participants.

Study design
This is an interventional study that plans to enroll 102 participants. Participants will be randomly assigned to receive either Varenicline or a placebo.
What's involved
You will take a pill daily for 12 months, with a short break in the 13th month. You will also have phone and in-person visits, various tests, imaging, questionnaires, and lab collections.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 months, which is the duration of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06679374

Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease

Recruiting
PHASE2Ages 45+InterventionalTreatment
Vikas Kotagal
~102 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:PlaceboVarenicline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in normal pace-dual task cost (npDTC) from baseline to 12 months.
Measured over Baseline, 12 months

Conditions

Parkinson Disease

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Mild cognitive disorderParkinson Disease

NCT06679374

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Vikas Kotagal, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Dawn Keys
[email protected]
734-615-4334
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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
Pregnancy (test within 48 hours of the PET imaging session in women of childbearing potential) or breastfeeding at the time of in-person screening visit
Participants with stage 4 or 5 chronic kidney disease at the time of in-person screening visit (estimated Creatinine Clearance \< 30 milliliters per minute)
Current, significant mood disorder at the time of in-person screening/enrollment visit defined as follows: persistent (lasting longer than 2 weeks) symptoms of depression or anxiety in the 30 days preceding informed consent, as determined by self-report
Evidence of active suicidal ideation as defined by an affirmative answer to either question 1 or 2 on the Columbia Suicide Severity Rating Scale (C-SSRS)
History of a myocardial infarction or unstable angina in the 90 days preceding enrollment visit
A current or previous history of epilepsy or any epileptic seizures in the 12 months preceding enrollment
Heavy alcohol use as defined by a score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT-self-report version) at the time of screening/enrollment visit
Participants that are unable to swallow pills
Participants with a history of allergic reaction to varenicline
Participants that are actively taking part in another ongoing interventional (i.e., not observational) clinical trial

What this trial measures

  • Change in normal pace-dual task cost (npDTC) from baseline to 12 months.Baseline, 12 months

    Normal pace-dual task cost is defined as the within-subject difference between normal pace walking speed without dual tasking to normal pace walking speed with dual tasking divided by normal pace walking speed without dual tasking, multiplied by 100.