Varenicline for Parkinson's Disease

(CRANE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Vikas Kotagal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Vikas Kotagal

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Parkinson's Disease.

I have mild memory or thinking problems due to Parkinson's disease.

My brain scan shows low cholinergic activity in a specific part.

Exclusion Criteria

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

I have used nicotine products or medications in the last 6 months.

My Parkinson's disease is advanced, with a score of 4 or higher.

Participant Groups

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.

Group I: Varenicline Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Varenicline is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Chantix for:

• Smoking cessation
• Dry eye disease

🇪🇺 Approved in European Union as Champix for:

• Smoking cessation

🇨🇦 Approved in Canada as Champix for:

• Smoking cessation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Michigan Ann Arbor, MI

Who Is Running the Clinical Trial?

Vikas Kotagal Lead Sponsor

National Institute of Neurological Disorders and Stroke (NINDS) Collaborator

References