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

Plain-Language Summary

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.

View on ClinicalTrials.gov