Actively Recruiting
AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease
Led by Xuanwu Hospital, Beijing · Updated on 2024-06-13
76
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
M
Michael J. Fox Foundation for Parkinson's Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
AV133 Longitudinal Imaging Study in Patients With Early and Prdromal Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 30 years or older at Parkinson's disease diagnosis
- Diagnosis of Parkinson's disease with at least two of the following: resting tremor, bradykinesia, or tonicity (must include resting tremor or bradykinesia); or asymmetric resting tremor or asymmetric bradykinesia
- Parkinson's disease diagnosis within 2 years of screening
- Hoehn & Yahr stage I or II at baseline
- AV133 PET scan showing vesicular monoamine transporter 2 deficiency
- Able to provide informed consent
- Not started on Parkinson's disease medication
- For prodromal Parkinson's disease: eligibility based on predictive criteria including olfactory dysfunction confirmed by testing
- For prodromal subjects, aged 60 years or older (or 30 years or older with certain genetic variants)
- AV133 deficiency confirmed by visual PET scan assessment
- Willing and medically able to discontinue certain medications (alpha-methyldopa, methylphenidate, amphetamine derivatives, modafinil) for at least five half-lives prior to PET imaging
You will not qualify if you...
- Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine, or other anti-Parkinson's medications
- Diagnosed with dementia or related cognitive impairment disorders
- Received medications interfering with PET dopamine transporter imaging (antipsychotics, metoclopramide, alpha-methyldopa, methylphenidate, reserpine, modafinil, amphetamine derivatives) within 1 month prior to screening
- Current clinically significant cardiovascular disease or abnormal ECG findings including QTc > 450 ms
- Taking medications known to cause QT prolongation
- Use of investigational drugs or devices within 60 days prior to baseline (excluding dietary supplements like coenzyme Q10)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuan Wu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
Z
zhang hui, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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