NCT06456684 AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease
| NCT ID | NCT06456684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xuanwu Hospital, Beijing |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 76 participants |
| Start Date | 2024-04-12 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 76 participants in total. It began in 2024-04-12 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06456684 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06456684 currently recruiting?
Yes, NCT06456684 is actively recruiting participants. Contact the research team at zhangxiang229@163.com for enrollment information.
Where is the NCT06456684 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06456684 clinical trial?
NCT06456684 is sponsored by Xuanwu Hospital, Beijing. The trial plans to enroll 76 participants.
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