Parkinson's gait hope: donepezil shows promise in tiny trial
NCT ID NCT06903910
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This small study tested whether donepezil (Aricept), a drug that boosts the brain chemical acetylcholine, could improve walking and balance in 6 people with Parkinson's disease. Researchers also looked at how brain shrinkage in a key area relates to gait problems. The goal is to find better treatments for disabling walking issues like shuffling and freezing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Donepezil (Aricept)
- What this could lead to
- If it works, this could point toward a treatment for walking and balance problems in Parkinson's disease.
- What could go wrong
- This was a very small study (6 people) and only looked at short-term effects. Results may not apply to everyone with Parkinson's.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
6 people
The number who actually took part.
- Started
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Nov 2024
- Finished
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Jan 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Female subjects are not considered to be of childbearing potential if they meet at least one of the following criteria as documented by the Investigator: * 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Virginia
Charlottesville, Virginia, 22903, United States
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Other studies related to the condition(s) this trial covers.
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