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

This study is testing how brain imaging can help track changes in people who have early or early signs of Parkinson's disease.

Quick facts

• Study type: Observational
• Enrollment: 76 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06456684 on ClinicalTrials.gov

What this trial studies

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Who should consider this trial

Good fit: Unknown

Not a fit: Unknown

Why it matters

Potential benefit: Unknown

How similar studies have performed: Unknown

Eligibility criteria

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).

Where this trial is running

Beijing, Beijing Municipality

• Xuan Wu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: zhang hui, Doctor

Conditions Parkinson Disease; PD; [18F]promethazine