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

NCT06456684 | Recruiting

• 1 other identifier: 114
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

PD; [18F]promethazine

Outcome Measures

Primary Outcomes (1)

• to assess the mean rate of change and variability of AV133 imaging results

  to assess the mean rate of change and variability of AV133 imaging results from baseline at 12 and 24 months follow-up in patients with prodromal and

  baseline the 12 months and 24 months

Study Arms (2)

early-stage Parkinson's disease

Diagnostic Test: Fluoro[18F]promethazine

prodromal Parkinson's disease

Diagnostic Test: Fluoro[18F]promethazine

Interventions

Fluoro[18F]promethazine DIAGNOSTIC_TEST

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

early-stage Parkinson's disease; prodromal Parkinson's disease

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

38 patients with early-stage Parkinson's disease and 38 patients with prodromal Parkinson's disease

You may qualify if:

• 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.

You may not qualify if:

• Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine, or other anti-Parkinson's disease medications.
• Diagnosed with dementia and related cognitive impairment disorders. Received any of the following medications that may interfere with PET imaging of the dopamine transporter protein within 1 month prior to screening: antipsychotics, metoclopramide, α-methyldopa, methylphenidate, reserpine, modafinil, or amphetamine derivatives.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The Michael J. Fox Foundation for Parkinson's Research: collaborator
• XINGIMAGING LLC: collaborator
• Naming MITRO Pharmaceutical Technology Co., Ltd: collaborator

Study Sites (1)

Xuan Wu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

zhang hui, Doctor

CONTACT

15811176880; zhangxiang229@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: June 13, 2024
• Study Start: April 12, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)