Fluoro[18F]promethazine for Parkinson's (NCT06456684)
Track brain protein loss annually
- Trial ID
- NCT06456684
- Official Title
- AV133 Longitudinal Imaging Study in Patients With Early and Prodromal Parkinson's Disease
- Goal
- Track brain protein loss annually
- Status
- RECRUITING
- Sponsor
- Xuanwu Hospital, Beijing
- Study Type
- OBSERVATIONAL
- Enrollment
- 76 participants
- Conditions
- Parkinson Disease
- Interventions
- Fluoro[18F]promethazine
Summary For Families
Goal: To track how a brain imaging marker called AV-133 changes over time in people with early Parkinson's and in people who have risk signs before a clear diagnosis, so the results can guide future treatment trials. Approach: Participants will have brain scans with AV-133 at the start and once a year for two years, plus motor, mood, and thinking tests and collection of blood and other samples; AV-133 highlights a brain protein called VMAT2 that can be reduced in Parkinson's. Eligibility: The study will enroll 38 people with early Parkinson's (diagnosed within 2 years, age 30 or older, mild stage, and not yet on Parkinson's medicines) and 38 people in the prodromal phase (usually age 60 or older unless they have certain genetic risks, must have loss of smell or other risk markers, and also not yet on Parkinson's medicines).
Locations
- Xuan Wu Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Fluoro[18F]promethazine. Goal: To track how a brain imaging marker called AV-133 changes over time in people with early Parkinson's and in people who have risk signs before a clear diagnosis, so the results can guide future treatment trials. Approach: Participants will have brain scans with AV-133 at the start and once a year for two years, plus motor, mood, and thinking tests and collection of blood and other samples; AV-133 highlights a brain protein called VMAT2 that can be reduced in Parkinson's. Eligibility: The study will enroll 38 people with early Parkinson's (diagnosed within 2 years, age 30 or older, mild stage, and not yet on Parkinson's medicines) and 38 people in the prodromal phase (usually age 60 or older unless they have certain genetic risks, must have loss of smell or other risk markers, and also not yet on Parkinson's medicines).
- Who can participate?
- Participants must be at least 30 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 2 years and 6 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?
- 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.
- How many visits does this trial involve?
- Imaging and assessments are done at baseline and every 12 months, with a 24-month follow-up and total study duration of approximately 27 months.