NCT06456684

AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease

AV133 Longitudinal Imaging Study in Patients With Early and Prodromal Parkinson's Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 76 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: —

Summary

A total of 38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease are planned to be enrolled in this study and examined for longitudinal changes in \[18F\]AV-133 through follow-up, thereby informing the design of future therapeutic trials utilizing \[18F\]AV-133 as a marker of disease progression.

Detailed description

This study is a longitudinal study designed to assess the progression of \[18F\]AV-133 imaging in patients with prodromal and early stages of Parkinson's disease . Approximately 38 patients with early PD and 38 subjects in the prodromal phase will be enrolled in the study. All subjects will undergo imaging assessment with \[18F\]AV-133 at baseline and every 12 months thereafter, clinical (motor, neuropsychiatric and cognitive) assessment, and biospecimen collection for bioanalysis. The study duration for each subject will be approximately 27 months, including a 60-day screening period and a 24-month follow-up assessment period. Data collection will be performed uniformly for all participants according to the protocol developed.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fluoro[18F]promethazine	It is the first F-18-labeled VMAT2 imaging agent for PET imaging that is currently being used in the clinic internationally. In the brains of Parkinson's disease (PD) patients, the target binding of fluoro\[18F\]promethazine was significantly reduced compared with that of normal controls, with an 81% reduction in the posterior region of the nucleus accumbens, a 70% reduction in the anterior region of the nucleus accumbens, and a 48% reduction in the caudate nucleus; the radioactivity uptake in the caudate nucleus of PD patients was correlated with the extent of their disease

Timeline

• Start date: 2024-04-12
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: China