RECRUITING

Investigating the Cholinergic Contribution to Gait Dysfunction in Parkinson's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating the Cholinergic Contribution to Gait Dysfunction in Parkinson's Disease

Quick Facts

Study Start:2024-11-01

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06903910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosis of PD by a neurologist as per UK Brain Bank criteria 2. Age 40 or older 3. Clinical evidence of gait dysfunction, as determined by a movement disorders neurologist. 4. Willingness and ability to comply with scheduled visits and study procedures. 5. Actively treated with a stable dose of levodopa or other anti-parkinsonian medications. 6. Able to ambulate without the use of an assistive device. 7. Serum chemistry from blood obtained at screening will need to be free from evidence of renal injury (elevated creatinine) or other significant metabolic abnormalities at the discretion of the examiner within 28 days of study initiation. 8. Subject agrees not to participate in another study with an investigational drug/treatment during this study and for 3 months following study completion. 9. Female subjects must not be breastfeeding and must have a negative serum pregnancy test at Visit 1. Women of childbearing potential (WOCBP) must use one of the following acceptable birth control methods as specified before enrollment and throughout the trial: * Surgical sterilization (bilateral tubal occlusion/ligation) prior to signing the informed consent form (ICF). * Intrauterine device in place for at least 3 months before the first dose of study drug and throughout the trial. * Barrier method (condom or diaphragm) with spermicide for at least 30 days before the first dose of the study drug and throughout the trial. * Surgical sterilization of the male partner (vasectomy at least 6 months before the first dose of study drug). * Hormonal contraceptives with a barrier method for at least 3 months before the first dose of the study drug and throughout the trial. * They have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at minimum one menstrual cycle prior to signing the ICF. * They are postmenopausal, defined as 1 year since the last menstrual period without an alternative medical cause or have a follicle-stimulating hormone (FSH) level in the menopausal range (defined as \>20 miU/mL and \<122 miU/mL) in women who are not using hormonal contraception or hormonal replacement therapy and are ≥50 years of age. * For women ≤50 years old, ≥2 years since her last menstrual period without an alternative.	1. Current use of donepezil, rivastigmine, galantamine, or memantine 2. Score of 3 or higher on the Anticholinergic Cognitive Burden Scale 3. Presence of a deep brain stimulator, or implantation of a deep brain stimulator during the study 4. Montreal Cognitive Assessment (MoCA) score less than 21 5. Known allergic reactions to donepezil or piperidine derivatives 6. Use of a different investigational drug/treatment within 3 months before the study 7. Presence of bradycardia for bradycardia (\<60bpm) and other significant arrhythmias (not counting simple first-degree heart block), severe COPD, severe asthma, peptic ulcer disease, or other severe, acute medical comorbidities that could affect the outcome of the study, for example acute end-stage CHF or acute pneumonia 8. Inability to obtain a brain MRI (presence of ferromagnetic metal inside the body, severe claustrophobia, etc) 9. Impairment in cognitive or decision-making abilities that would impede the participant's ability to consent for themselves. Of note, physical impairment or disability may still require the use of a legally authorized representative or surrogate, and would not in itself be an exclusion.

Inclusion Criteria

Exclusion Criteria

1. Diagnosis of PD by a neurologist as per UK Brain Bank criteria
2. Age 40 or older
3. Clinical evidence of gait dysfunction, as determined by a movement disorders neurologist.
4. Willingness and ability to comply with scheduled visits and study procedures.
5. Actively treated with a stable dose of levodopa or other anti-parkinsonian medications.
6. Able to ambulate without the use of an assistive device.
7. Serum chemistry from blood obtained at screening will need to be free from evidence of renal injury (elevated creatinine) or other significant metabolic abnormalities at the discretion of the examiner within 28 days of study initiation.
8. Subject agrees not to participate in another study with an investigational drug/treatment during this study and for 3 months following study completion.
9. Female subjects must not be breastfeeding and must have a negative serum pregnancy test at Visit 1. Women of childbearing potential (WOCBP) must use one of the following acceptable birth control methods as specified before enrollment and throughout the trial:
* Surgical sterilization (bilateral tubal occlusion/ligation) prior to signing the informed consent form (ICF).
* Intrauterine device in place for at least 3 months before the first dose of study drug and throughout the trial.
* Barrier method (condom or diaphragm) with spermicide for at least 30 days before the first dose of the study drug and throughout the trial.
* Surgical sterilization of the male partner (vasectomy at least 6 months before the first dose of study drug).
* Hormonal contraceptives with a barrier method for at least 3 months before the first dose of the study drug and throughout the trial.
* They have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at minimum one menstrual cycle prior to signing the ICF.
* They are postmenopausal, defined as 1 year since the last menstrual period without an alternative medical cause or have a follicle-stimulating hormone (FSH) level in the menopausal range (defined as \>20 miU/mL and \<122 miU/mL) in women who are not using hormonal contraception or hormonal replacement therapy and are ≥50 years of age.
* For women ≤50 years old, ≥2 years since her last menstrual period without an alternative.

1. Current use of donepezil, rivastigmine, galantamine, or memantine
2. Score of 3 or higher on the Anticholinergic Cognitive Burden Scale
3. Presence of a deep brain stimulator, or implantation of a deep brain stimulator during the study
4. Montreal Cognitive Assessment (MoCA) score less than 21
5. Known allergic reactions to donepezil or piperidine derivatives
6. Use of a different investigational drug/treatment within 3 months before the study
7. Presence of bradycardia for bradycardia (\<60bpm) and other significant arrhythmias (not counting simple first-degree heart block), severe COPD, severe asthma, peptic ulcer disease, or other severe, acute medical comorbidities that could affect the outcome of the study, for example acute end-stage CHF or acute pneumonia
8. Inability to obtain a brain MRI (presence of ferromagnetic metal inside the body, severe claustrophobia, etc)
9. Impairment in cognitive or decision-making abilities that would impede the participant's ability to consent for themselves. Of note, physical impairment or disability may still require the use of a legally authorized representative or surrogate, and would not in itself be an exclusion.

Contacts and Locations

Study Contact

Lauren A Miller, BS, MS

CONTACT

434-982-6599

fdk5dn@uvahealth.org

Hannah Caballero, MSW

CONTACT

htp5aw@uvahealth.org

Principal Investigator

William A Dalrymple, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: University of Virginia

William A Dalrymple, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

Gait
Cholinergic

Additional Relevant MeSH Terms

Parkinson Disease