Parkinson's Trial NCT07642908
Link brain chemicals to walking
- Trial ID
- NCT07642908
- Official Title
- Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation
- Goal
- Link brain chemicals to walking
- Status
- RECRUITING
- Sponsor
- University of Michigan
- Study Type
- OBSERVATIONAL
- Enrollment
- 15 participants
- Conditions
- Parkinson Disease
Summary For Families
Researchers are studying how a common genetic change called LRRK2 affects brain systems in people with Parkinson's, especially the brain chemical system that supports attention and memory, and whether those differences relate to thinking problems or to balance and walking difficulties. Participants will have whole-brain positron emission tomography scans that map nerve endings that use a key brain chemical, a second PET scan that looks at dopamine nerve terminals, magnetic resonance imaging, and tests of thinking, movement, sensation, and questionnaires so researchers can link brain chemistry with symptoms. They are enrolling people aged 45 and older who have Parkinson's and a confirmed LRRK2 mutation; people who cannot have magnetic resonance imaging, who regularly take certain anticholinergic or memory drugs, who have had deep brain stimulation, who are pregnant or unable to consent, or who have other major health or safety issues are not eligible.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Deep brain stimulation: Cannot join after DBS surgery (deep brain stimulation) (criteria text: "history of deep brain stimulation surgery")
- LRRK2 gene: Must carry an LRRK2 gene variant (criteria text: "presence of lrrk2 mutation as confirmed by referral from um movement disorders clinic, medical record review, or participation in the pdgeneration study")
Locations
- University of Michigan, Ann Arbor, Michigan, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07642908. It is the one about "Link brain chemicals to walking". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. Researchers are studying how a common genetic change called LRRK2 affects brain systems in people with Parkinson's, especially the brain chemical system that supports attention and memory, and whether those differences relate to thinking problems or to balance and walking difficulties. Participants will have whole-brain positron emission tomography scans that map nerve endings that use a key brain chemical, a second PET scan that looks at dopamine nerve terminals, magnetic resonance imaging, and tests of thinking, movement, sensation, and questionnaires so researchers can link brain chemistry with symptoms. They are enrolling people aged 45 and older who have Parkinson's and a confirmed LRRK2 mutation; people who cannot have magnetic resonance imaging, who regularly take certain anticholinergic or memory drugs, who have had deep brain stimulation, who are pregnant or unable to consent, or who have other major health or safety issues are not eligible.
- Who can participate?
- Participants must be at least 45 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); MRI scan (non-invasive); Questionnaires & surveys (non-invasive); Walking & movement tests (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.