Donepezil for Parkinson's Disease

Overseen By Hannah Caballero, MSW

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Virginia

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

People with Parkinson's disease often experience problems with 'gait' and balance. Gait refers to the way a person moves while walking, such as their speed and length of steps. People with Parkinson's may experience slowness of movement, shuffle their feet, or have periods of 'freezing', during which their feet feel like they are stuck to the floor. Some people may struggle to maintain their balance and fall. These symptoms are frequently disabling and can lead to a worse quality of life. The nervous system is your body's messaging system - it helps different parts of your body communicate with one another. Neurotransmitters are chemicals that deliver those messages from one part of the body to another. The purpose of this study is to determine if the use of ARICEPT (Donepezil hydrochloride) improves gait and balance and its relation to the size of an area of the brain called "Cholinergic Nucleus 4" (Ch4). The study team is also studying how degeneration (breakdown and eventual loss) in Ch4 contributes to problems with gait and balance. One way this may happen is through the loss of a chemical in the brain called acetylcholine. Acetylcholine is a neurotransmitter and its activity is associated with alertness, thinking, and the ability to move. Taking a drug that increases acetylcholine, such as ARICEPT, may improve gait and balance. By better understanding this relationship, we may be able to improve the treatment of gait and balance problems in the future.

Research Team

William A Dalrymple, MD

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who have difficulties with walking and balance. The study aims to understand if a medication, ARICEPT (Donepezil hydrochloride), can help improve these issues.

Inclusion Criteria

I can walk without help from devices like canes or walkers.

Subject agrees not to participate in another study with an investigational drug/treatment during this study and for 3 months following study completion

I am not breastfeeding, have a negative pregnancy test, and if able to bear children, I use birth control.

Exclusion Criteria

Presence of specific medical conditions that could affect the outcome of the study

Score of 3 or higher on the Anticholinergic Cognitive Burden Scale

I am currently taking medication for memory problems.

Treatment Details

Interventions

• Donepezil (Cholinesterase Inhibitor)

Trial Overview The trial is testing whether Donepezil, a drug that increases levels of acetylcholine in the brain, can improve gait and balance in people with Parkinson's by affecting an area of the brain called Cholinergic Nucleus 4.

Participant Groups

Group I: Donepezil Experimental Treatment 1 Intervention

Patients with Parkinson's disease and gait dysfunction will be enrolled. We will measure gait metrics and obtain an MRI at baseline, then everyone will begin donepezil (5mg nightly for 4 weeks, followed by 10mg nightly). There will be a telephone check in at week 6, then at week 12 they will return for repeat gait metrics

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+