Prodromal Parkinsons Disease study: [18F] AV-133 PET Imaging
Official title Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)
ClinicalTrials.gov ID: NCT07265596
What this study is testing
What is [18F] AV-133 PET Imaging?
[18F] AV-133 PET Imaging is an investigational medicine, being studied as a potential treatment for prodromal parkinsons disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how brain images change over time in people with early signs of Parkinson's disease.
- Who it's for
- The study is looking for people who have early signs of Parkinson's disease but have not yet been fully diagnosed.
- What's involved
- Participants will get a special brain scan and complete health checks, including tests for movement, mood, and thinking, at the start and during follow-up visits.
- Time commitment
- The study lasts up to 24 months and requires visits for scans and health assessments.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
- 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...
- 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...
You likely can't join if
- Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or...
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
See the full eligibility criteria
- A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
- 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...
- 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...
- 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.
- 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...
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Philadelphia, Pennsylvania, United States
- London, Britain, United Kingdom
- Newcastle upon Tyne, Tyne and Wear, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Philadelphia, Pennsylvania, United States; London, Britain, United Kingdom; Newcastle upon Tyne, Tyne and Wear, United Kingdom. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.