NCT07830654RecruitingPhase 2
This Protocol is a Sub-study Under the PPMI Program. It is a Longitudinal, Single-center Study to Assess the Performance of [18F]AV-133 Imaging Using High and Standard Resolution PET in Individuals Enrolled With Parkinson's Disease (PD) for up to 12 Months.
A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F]AV- 133 in Parkinson's Disease [Dual PET AV-133 in PD]
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
The study is a longitudinal, single-center study to assess progression of \[18F\]AV-133 imaging in PD participants. Participants will be followed for up to 12 months. Approximately 45 PD participants and 5 healthy control participants will be recruited from the ongoing PPMI Clinical 002 study. Participants will be comprehensively assessed at Baseline and follow up according to the Schedule of Activities. Participants will undergo PET imaging assessments with \[18F\]AV-133. After tracer injection, participants will be imaged on PET cameras at each imaging timepoint-one with the NX camera and one with a standard PET camera-in accordance with the Image Acquisition Protocol (IAP).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 15 Sept 2026
- Start date
- 25 Sept 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Diseases
- Parkinson disease
- NCT number
- NCT07830654
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- From 25 Sept 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received any of the following medications that might interfere with \[18F\]AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline \[18F\]AV-133 injection.
Other illness
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Who the study is looking for
- Participants over the age of 18 who are enrolled in the PPMI Clinical protocol with a diagnosis of Parkinson's disease (PD) or Healthy Control participants enrolled in the PPMI Clinical protocol.
- Able to provide informed consent.
- Male or Female (females must meet additional criteria specified below as applicable)
- Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]AV-133
- Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
- Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
- Females of childbearing potential must not be pregnant, breastfeeding or lactating.
- Includes a negative urine pregnancy test prior to injection of \[18F\]AV-133 on day of PET scan.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute for Neurodegenerative Disorders Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.