Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Along with the study medication participants will have visits (over the phone and in person), various tests and imaging, questionnaires, and laboratory collections."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether taking varenicline for one year can lower fall risk and help people do another task while walking. It is for people with Parkinson disease, mild thinking or memory problems, and certain changes on a brain scan. Participants are assigned by chance to take varenicline or a placebo, a pill with no active medicine.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Parkinson disease confirmed using the study’s diagnostic rules.
- Have a PET brain scan showing nerve supply that uses acetylcholine, a brain chemical, in the lowest third of the normal range in a vision-related brain area.
- Can give informed consent, or have a legally authorized representative who can co-sign the consent form.
- Have mild thinking or memory problems linked to Parkinson disease.
Who can't join
- Have a Parkinson-like condition other than Parkinson disease, or advanced Parkinson disease with a movement rating score of 4 or higher.
- Take certain medicines that block dopamine, trihexyphenidyl, benztropine, or certain cholinesterase inhibitors. Have used nicotine products or varenicline now or within the past 6 months.
- Have certain stroke damage or a mass in the back of the brain that prevents scan analysis. Cannot safely have an MRI, have severe fear of enclosed spaces that prevents scans, or cannot have more research radiation exposure.
- Are pregnant or breastfeeding, or have severe kidney disease at stage 4 or 5.
- Have depression or anxiety symptoms lasting more than 2 weeks in the past 30 days, or current suicidal thoughts as defined by the study’s screening questions.
- Had a heart attack or unstable chest pain within 90 days before enrollment. Have a history of epilepsy or had an epileptic seizure within the past 12 months.
- Have heavy alcohol use, defined as a score of 8 or higher on the study’s alcohol questionnaire.
- Cannot swallow pills, have had an allergic reaction to varenicline, or are taking part in another trial that tests a treatment or other intervention.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 (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
Study sites (1)
MI
- University of Michigan · Ann Arbor, MI 48109Dawn Keys · Study contact · 734-615-4334 · dmkeys@med.umich.eduVikas Kotagal, MD · Principal investigatorMore trials in Ann Arbor