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

Recruiting now

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT06456684

Run by

Xuanwu Hospital, Beijing

People needed

76

Starts

2024-04-12

Expected to finish

2026-12-31

Last updated by the study team

2024-06-13

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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 it is running

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

Full record on ClinicalTrials.gov

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