Detect early loss of dopamine
- Trial ID
- NCT06456684
- Official Title
- AV133 Longitudinal Imaging Study in Patients With Early and Prodromal Parkinson's Disease
- Goal
- Detect early loss of dopamine
- Status
- RECRUITING
- Sponsor
- Xuanwu Hospital, Beijing
- Study Type
- OBSERVATIONAL
- Enrollment
- 76 participants
- Conditions
- Parkinson Disease
- Interventions
- Fluoro[18F]promethazine
Summary For Families
Goal: find and track early loss of dopamine nerve terminals in people with very early or prodromal Parkinson's by detecting reductions in VMAT2, a protein that reflects how healthy dopamine storage in nerve endings is. Approach: participants undergo AV133 PET scans using Fluoro[18F]promethazine, a radioactive tracer that binds VMAT2 so clinicians can visualize and quantify dopamine terminal loss over time; this is an imaging test not a treatment, and people already on levodopa or other Parkinson medications are excluded because those drugs can alter the PET signal. Eligibility: looking for adults 30 and older with a clinical Parkinson's diagnosis within two years and Hoehn and Yahr stage I or II who show AV133 changes, plus a prodromal group generally 60 and older or 30 and older if they have certain genetic risks; everyone must be able to consent and not yet started on PD medications, and some stimulants or interfering drugs must be stopped before imaging.
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: find and track early loss of dopamine nerve terminals in people with very early or prodromal Parkinson's by detecting reductions in VMAT2, a protein that reflects how healthy dopamine storage in nerve endings is. Approach: participants undergo AV133 PET scans using Fluoro[18F]promethazine, a radioactive tracer that binds VMAT2 so clinicians can visualize and quantify dopamine terminal loss over time; this is an imaging test not a treatment, and people already on levodopa or other Parkinson medications are excluded because those drugs can alter the PET signal. Eligibility: looking for adults 30 and older with a clinical Parkinson's diagnosis within two years and Hoehn and Yahr stage I or II who show AV133 changes, plus a prodromal group generally 60 and older or 30 and older if they have certain genetic risks; everyone must be able to consent and not yet started on PD medications, and some stimulants or interfering drugs must be stopped before imaging.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 6 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.