[18F]MK-0947 for Parkinson's (NCT07348250)
Safely show brain protein buildup
- Trial ID
- NCT07348250
- Official Title
- An Open-label Study to Evaluate Brain α-Synuclein Deposition Using Positron Emission Tomography (PET) and [18F]MK-0947 in Patients With Parkinson's Disease
- Goal
- Safely show brain protein buildup
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- Invicro
- Study Type
- INTERVENTIONAL
- Enrollment
- 22 participants
- Conditions
- Parkinson's Disease (PD), Parkinson's Disease, Parkinson's Disease (Disorder)
- Interventions
- [18F]MK-0947
Summary For Families
Researchers are testing a new imaging tracer to help doctors see where a protein called alpha-synuclein builds up in the brain using Positron Emission Tomography (PET) scans, with the goal of improving diagnosis and tracking of Parkinson's disease. The tracer is given by injection and the study will look at safety, how the tracer moves through the body, and how much radiation it gives off, using PET scans that can last up to two hours, blood samples, and sometimes a magnetic resonance imaging scan for comparison. The study has two parts: one compares brain images between people with Parkinson's and healthy older adults, and the other measures whole-body radiation in healthy volunteers. They are enrolling adults with Parkinson's aged 40 to 80 and healthy volunteers (some parts require ages 18 to 50, others 40 to 80), with screening tests to confirm eligibility.
Locations
- Invicro (dba Perceptive), New Haven, Connecticut, United States
- XingImaging LLC, New Haven, Connecticut, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [18F]MK-0947. Researchers are testing a new imaging tracer to help doctors see where a protein called alpha-synuclein builds up in the brain using Positron Emission Tomography (PET) scans, with the goal of improving diagnosis and tracking of Parkinson's disease. The tracer is given by injection and the study will look at safety, how the tracer moves through the body, and how much radiation it gives off, using PET scans that can last up to two hours, blood samples, and sometimes a magnetic resonance imaging scan for comparison. The study has two parts: one compares brain images between people with Parkinson's and healthy older adults, and the other measures whole-body radiation in healthy volunteers. They are enrolling adults with Parkinson's aged 40 to 80 and healthy volunteers (some parts require ages 18 to 50, others 40 to 80), with screening tests to confirm eligibility.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 Phase 1 trial is estimated to last approximately 10 months.
- 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Blood draw (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.