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.
Ready to participate?
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
100 (estimated)
Sponsor
Michael J. Fox Foundation for Parkinson's Research · Other
Who this trial is looking for
This trial is looking for adults who have early signs of Parkinson's disease. Participants will have regular check-ups and use a specific imaging method to track changes over two years.
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 early signs of Parkinson's disease.
I can provide informed consent.
I am either a female with non-childbearing potential or using effective birth control.
I am not pregnant, breastfeeding, or lactating if I am of childbearing potential.
You may not be able to join if
I have taken tetrabenazine, methylphenidate, reserpine, or an amphetamine derivative in the last month.
I have a medical or psychiatric condition 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, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and …
The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
2. Able to provide informed consent.
3. Male or Female (females must meet additional criteria specified below as applicable)
* Females must be of non-childbea…
Inclusion Criteria:
1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
2. Able to provide informed consent.
3. 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.
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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