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Nicotinic Acetylcholine Receptor Agonist

Varenicline for Parkinson's Disease (CRANE Trial)

Phase 2
Waitlist Available
Led By Vikas Kotagal, MD
Research Sponsored by Vikas Kotagal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Must not have
Participants with stage 4 or 5 chronic kidney disease at the time of in-person screening visit (estimated Creatinine Clearance < 30 milliliters per minute)
A current or previous history of epilepsy or any epileptic seizures in the 12 months preceding enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months

Summary

This trial will test if taking Varenicline for one year can reduce the risk of falling and improve the ability to multitask while walking. Participants will be randomly assigned to either receive Varenic

Who is the study for?
This trial is for individuals with Parkinson's Disease and overactive bladder who may be at risk of falling. Participants will undergo screening to ensure they meet the study requirements before being randomly assigned to receive either Varenicline or a placebo.
What is being tested?
The trial is testing if Varenicline can reduce falls and improve multitasking while walking in patients with Parkinson's Disease, compared to a placebo. It involves regular visits, tests, imaging studies, questionnaires, and lab collections over one year.
What are the potential side effects?
Possible side effects of Varenicline include nausea, sleep disturbances (like insomnia or vivid dreams), constipation, gas and/or vomiting. Some people might also experience changes in taste or dry mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Parkinson's Disease.
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My brain scan shows low cholinergic activity in a specific part.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is severely reduced.
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I have had epilepsy or seizures in the last year.
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I cannot swallow pills.
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My condition is a Parkinson-like syndrome, not Parkinson's disease.
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My Parkinson's disease is advanced, with a score of 4 or higher.
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I am currently taking certain medications for my condition as listed in the study protocol.
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My brain scan shows a stroke or mass that affects image analysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in normal pace-dual task cost (npDTC) from baseline to 12 months.
Secondary study objectives
Number of falls from the first dose of study drug to the 12-month visit

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VareniclineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,381 Previous Clinical Trials
652,198 Total Patients Enrolled
Vikas KotagalLead Sponsor
Vikas Kotagal, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
58 Total Patients Enrolled
~68 spots leftby Jan 2027
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