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.
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
50 (estimated)
Sponsor
Michael J. Fox Foundation for Parkinson's Research · Other
Who this trial is looking for
This trial is looking for individuals diagnosed with Parkinson's disease or healthy control participants. Taking part involves regular assessments and imaging for up to 12 months using a specific PET imaging method.
Are You a Good Fit for This Trial?
Must not be takingTetrabenazineMethylphenidateReserpineAmphetamine
You may be able to join if
I am over 18 years old
I have been diagnosed with Parkinson's disease or I am a healthy control
I can provide informed consent
If I am female, I am either past childbearing age or using effective birth control
If I am female and of childbearing potential, I am not pregnant or breastfeeding
You may not be able to join if
I have taken medications like tetrabenazine or amphetamines in the last month
I have other medical or psychiatric conditions that may prevent me from participating
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Acti…
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Able to provide informed consent.
3. Male or Female (females must meet additi…
Inclusion Criteria:
1. 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.
2. Able to provide informed consent.
3. Male or Female (females must meet additional criteria specified below as applicable)
1. 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.
2. 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.
Exclusion Criteria:
1. 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.
2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
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