Actively Recruiting
Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease
Led by Vikas Kotagal · Updated on 2026-03-31
102
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
Sponsors
V
Vikas Kotagal
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson disease based on the Movement Disorders Society Clinical Diagnostic Criteria at baseline screening/enrollment
- Occipital association cortex cholinergic denervation in the lowest third of normal range on F-fluoroethoxybenzovesamicol (FEOBV) PET scan
- Ability to provide informed consent or have a legally authorized representative to co-sign consent
- Mild cognitive impairment consistent with Parkinson disease mild cognitive impairment (PD-MCI)
You will not qualify if you...
- Atypical Parkinsonian conditions other than Parkinson disease
- Use of certain dopamine blocking, anticholinergic, or cholinesterase inhibitor drugs at screening
- Modified Hoehn and Yahr score of 4.0 or higher at screening
- Use of any nicotine-containing products or medications within 6 months before screening
- Evidence of stroke with cortical and subcortical involvement or occipital lobe mass on MRI
- Contraindications to MRI such as pacemaker, metallic fragments near eyes or spinal cord, or cochlear implant
- Severe claustrophobia preventing MRI or PET imaging
- Participation in research involving ionizing radiation
- Pregnancy or breastfeeding at screening
- Stage 4 or 5 chronic kidney disease with creatinine clearance less than 30 mL/min at screening
- Current significant mood disorder lasting over 2 weeks in past 30 days
- Active suicidal ideation based on Columbia Suicide Severity Rating Scale
- Myocardial infarction or unstable angina within 90 days before enrollment
- History of epilepsy or seizures within 12 months before enrollment
- Heavy alcohol use defined by AUDIT score of 8 or higher at screening
- Inability to swallow pills
- History of allergic reaction to varenicline
- Participation in another ongoing interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
D
Dawn Keys
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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