[18F] AV-133 PET Imaging for Parkinson's Disease

Recruiting at 7 trial locations

Overseen By Jessica Dimos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Michael J. Fox Foundation for Parkinson's Research

Must not be taking: Tetrabenazine, Methylphenidate, others

Disqualifiers: Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how a special imaging agent, [18F] AV-133, can help track the progression of early Parkinson's disease. Participants will receive three injections over 24 months to observe changes in their condition over time. The trial seeks individuals identified in the early stages of Parkinson's who can commit to follow-up visits. This study will help researchers better understand the disease and potentially improve future treatments.

As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like tetrabenazine, methylphenidate, reserpine, or amphetamine derivatives at least one month before the trial starts, as they can interfere with the imaging process.

Is there any evidence suggesting that [18F] AV-133 is likely to be safe for humans?

Research has shown that [18F] AV-133 is used in PET scans to study Parkinson's disease. One study detected brain changes related to Parkinson's over two years using this imaging method. Importantly, safety data indicate that the radiation dose from these scans is low, making the procedure generally well-tolerated.

Previous research has not reported significant side effects from using [18F] AV-133, suggesting the treatment is safe for humans. This is especially reassuring since the trial closely monitors participants over a long period. Participants in similar studies have not experienced major adverse effects, which should comfort those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Parkinson's disease focus on managing symptoms with medications like levodopa, dopamine agonists, or MAO-B inhibitors. However, [18F] AV-133 is unique because it uses a PET imaging agent to provide a more detailed view of the brain's dopamine system. This new approach could help identify Parkinson's disease at an earlier, prodromal stage, potentially before significant symptoms appear. Researchers are excited about [18F] AV-133 because it targets the disease's progression in a way that existing treatments do not, offering hope for earlier and more precise interventions.

What evidence suggests that [18F] AV-133 PET imaging is effective for assessing Parkinson's disease?

Research has shown that a special type of brain scan, called [18F] AV-133 PET imaging, can effectively detect Parkinson's disease. This scan targets a protein called VMAT2, which moves chemicals in brain cells. Studies have found that [18F] AV-133 can reveal brain changes linked to Parkinson's over a 2-year period. The scan provides detailed images that help track the disease's progression. This trial will involve participants with prodromal Parkinson's disease receiving [18F] AV-133 PET imaging to assess its utility in spotting early signs of Parkinson's and monitoring its development. ^{1 2 4 6 7}

Who Is on the Research Team?

Ken Marek, MD

Principal Investigator

Institute for Neurodegenerative Disorders

Are You a Good Fit for This Trial?

This trial is for individuals who are in the early stages of Parkinson's Disease, specifically those considered 'Prodromal', meaning they show early signs but not full-blown Parkinson's. They will be part of a study that tracks changes over up to 24 months and involves around 100 participants from multiple locations.

Inclusion Criteria

Able to provide informed consent

I am not able to have children, or I use effective birth control.

I am over 18 and confirmed to proceed with a Parkinson's study visit.

Exclusion Criteria

Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation

I haven't taken TBZ, methylphenidate, reserpine, or amphetamines in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo comprehensive baseline assessments including [18F]AV-133 PET imaging and clinical evaluations

1 visit

1 visit (in-person)

Follow-up Imaging and Assessments

Participants undergo repeat [18F]AV-133 PET imaging and clinical assessments at 12 and 24 months

24 months

2 visits (in-person) at 12 and 24 months

Follow-up

Participants are monitored for safety and effectiveness after imaging assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F] AV-133

Trial Overview [18F] AV-133 PET Imaging is being tested to see how it can help track the progression of Parkinson's Disease in its early stages. Participants will undergo this imaging technique alongside other clinical assessments related to motor skills, neuropsychiatric health, cognition, and biomarkers.

How Is the Trial Designed?

Group I: Prodromal Parkinson's disease (PD) Experimental Treatment 1 Intervention

Prodromal Parkinson's disease participants enrolled in the PPMI Clinical 002 study will receive 3 injections of \[18F\] AV-133 and imaging procedures over the course of 24 months.

Who Is Running the Clinical Trial?

Michael J. Fox Foundation for Parkinson's Research

Lead Sponsor

Trials

117

Recruited

537,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37816639/

Using 18F-AV-133 VMAT2 PET Imaging to Monitor ... This study provides Class IV evidence that VMAT2 PET can detect patients with Parkinson disease and quantify progression over a 2-year window.

2. ppmi-info.org ppmi-info.org/sites/default/files/docs/PPMI_030_Dual_PET_AV133_in_Prodromal_PD_Protocol_v1.0_16July2025_Signed.pdf

protocol Using 18F-AV-133 VMAT2 PET Imaging to Monitor Progressive. Nigrostriatal Degeneration in Parkinson Disease. Neurology, 101(22), E2314–E2324 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0969805112001229

Imaging of VMAT2 binding sites in the brain by 18F-AV-133 The radiochemical purity of the 18F-AV-133, whether prepared by SPE or by HPLC, was excellent (> 99%). PET scans of normal and PD monkey brains showed an ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/65/supplement_2/241196

First-in-human study of D6-[18F]FP-(+)-DTBZ, a novel VMAT2 ... Results: In this study, D6-[18F]FP-(+)-DTBZ dosimetry revealed an effective dose of 37.1 ± 7.2 μSv/MBq, with the liver receiving the highest ...

5. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000207748

Using 18F-AV-133 VMAT2 PET Imaging to Monitor ... This study provides Class IV evidence that VMAT2 PET can detect patients with Parkinson disease and quantify progression over a 2-year window.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01550484

A Trial of 18F-AV-133 Positron Emission Tomography (PET ... The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to differentiate subjects with Parkinson's Disease from other movement ...

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/1107803

In Vivo Assessment of Vesicular Monoamine Transporter ... [18F]AV-133 PET has been shown to detect VMAT2 reductions in PD. ... To assess the integrity of monoaminergic innervation as a differentiating feature in ...