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New treatment option for Parkinson Disease
Official title Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease
ClinicalTrials.gov ID: NCT06679374
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson disease.
Also referred to as Chantix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- Participants with a PD diagnosis based on the Movement Disorders Society Clinical Diagnostic Criteria for Parkinson's Disease at the time of baseline...
- Participants with occipital association cortex cholinergic denervation in the lowest tertile of the normal range on F-fluoroethoxybenzovesamicol...
- Participants with legally authorized representatives (LARs) able to co-sign documented informed consent or participants that have capacity to provide...
- Mild Cognitive Impairment consistent with Parkinson disease Mild Cognitive Impairment (PD-MCI)
You likely can't join 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...
- 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...
- Evidence of a stroke with both cortical and subcortical involvement or occipital lobe mass lesion on structural magnetic brain imaging (MRI) obtained...
- Participants where magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic...
See the full eligibility 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...
- Mild Cognitive Impairment consistent with Parkinson disease Mild Cognitive Impairment (PD-MCI)
- 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...
- 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...
- 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...
- 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...
- 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 treatment (i.e., not observational) clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.