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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
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• Clinical diagnosis of Parkinson's disease: Men or women aged 30 years or older at the time of diagnosis of Parkinson's disease.

• Patients must have at least two of the following: resting tremor, bradykinesia, tonicity (must have resting tremor or bradykinesia); or asymmetric resting tremor or asymmetric bradykinesia.

• Time to diagnosis of Parkinson's disease at screening was 2 years or less. Hoehn \& Yahr staging stage I or II at baseline. AV133 PET scan suggestive of vesicular monoamine transporter 2 (VMAT2) deficiency.

• Able to provide informed consent. Not yet started on PD medication.

• Clinical diagnosis of Parkinson's disease in the prodromal phase: Subjects confirmed eligible based on existing predictive criteria Olfactory dysfunction confirmed by olfactory testing. Other predictive criteria based on general risk, such as first-degree biological relatives, known Parkinson's disease risk including RBD, or known genetic variants associated with Parkinson's disease risk (LRRK2 or GBA).

• Men or women 60 years or older (or 30 years or older for subjects with SNCA or rare genetic variants such as Parkin or Pink1) AV133 deficiency as determined by visual assessment (screening PET scan) Subjects taking any of the following medications: α-methyldopa, methylphenidate, amphetamine derivatives, or modafinil must be willing and medically able to discontinue the medication for at least 5 half-lives prior to PET imaging.

• Able to provide informed consent. Not yet started on PD medication.

Locations
Other Locations
China
Xuan Wu Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
zhang hui, Doctor
zhangxiang229@163.com
15811176880
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 76
Treatments
early-stage Parkinson's disease
prodromal Parkinson's disease
Related Therapeutic Areas
Sponsors
Collaborators: The Michael J. Fox Foundation for Parkinson's Research, Naming MITRO Pharmaceutical Technology Co., Ltd, XINGIMAGING LLC
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov