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

June 10, 2024 updated by: Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuan Wu Hospital, Capital Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria：

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.

Current clinically significant cardiovascular disease or screening ECG abnormalities (including but not limited to QTc > 450 ms) Currently taking medications known to cause QT prolongation; Use of an investigational drug or device within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
early-stage Parkinson's disease
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
prodromal Parkinson's disease
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess the mean rate of change and variability of AV133 imaging results
Time Frame: baseline the 12 months and 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Collaborators

XINGIMAGING LLC
The Michael J. Fox Foundation for Parkinson's Research
Naming MITRO Pharmaceutical Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114 (Other Identifier: Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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