[18F]PI-2620 for Parkinson's Disease

Overseen By Ashley Romano, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Dopamine blockers, Amphetamines

Disqualifiers: Other neurological disorders, 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: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new imaging method to understand how the protein tau affects individuals with Parkinson's disease, Progressive Supranuclear Palsy (PSP), and Corticobasal Syndrome (CBS). The researchers aim to gain insights into these conditions using a special tracer, [18F]PI-2620, in conjunction with a high-resolution PET camera. Participants may qualify if they have been diagnosed with Parkinson's, PSP, or CBS and experience symptoms such as movement issues or cognitive decline. Healthy individuals enrolled in specific studies are also eligible. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

You might need to stop taking certain medications that could interfere with the imaging, such as alpha methyldopa, methylphenidate, and others, for a period before the scan. If you're taking dopamine receptor blockers or similar drugs, you should not have taken them within 6 months before the screening. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that [18F]PI-2620 is likely to be safe for humans?

Research has shown that [18F]PI-2620 has promising safety results from earlier studies. In one study, 26 people with conditions like Alzheimer's and progressive supranuclear palsy used [18F]PI-2620. The results indicated that it was well-tolerated, with no major side effects, suggesting that [18F]PI-2620 is generally safe for people with neurodegenerative diseases.

Moreover, [18F]PI-2620 is in a later stage of clinical trials, which usually means more safety information is available. This stage is typically reached after earlier trials have shown the treatment is safe for humans. While individual experiences can vary, current evidence suggests that [18F]PI-2620 is a safe option for this study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about [18F]PI-2620 because it offers a new way to visualize and track tau protein in the brain, which is crucial for understanding Parkinson's Disease progression. Unlike existing treatments that mainly focus on managing symptoms with medications like Levodopa, [18F]PI-2620 provides detailed imaging that could lead to more precise diagnoses and personalized treatment plans. This imaging agent targets tau deposits, which are associated with neurodegenerative processes, potentially offering insights that current therapies can't provide.

What evidence suggests that [18F]PI-2620 might be an effective treatment for Parkinson's Disease?

Research has shown that the tau tracer [18F]PI-2620 effectively detects tau protein in the brain, which is linked to conditions like Parkinson's disease and other tau-related disorders. In studies, [18F]PI-2620 outperformed earlier tracers, particularly in conditions such as progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS). This trial will evaluate [18F]PI-2620 in various participant groups, including those with Parkinson's Disease, those with tauopathies like PSP and CBS, and healthy participants. Specifically, for PSP, [18F]PI-2620 demonstrated a strong ability to identify the disease. These findings suggest that [18F]PI-2620 holds promise for detecting tau-related issues in the brain, potentially improving diagnosis and understanding of these conditions. ^{5 6 7 8 9}

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 with Parkinson's Disease, specifically those who have either the sporadic form or a genetic variant called LRRK2. Participants will undergo advanced imaging to assess tau protein buildup in their brains.

Inclusion Criteria

I am between 45 and 85 years old.

I am not pregnant, breastfeeding, or planning to become pregnant during the study.

Ability to comply with the study procedures and attend follow-up visits

Exclusion Criteria

Any other medical or psychiatric condition or lab abnormality that might preclude participation

I haven't taken certain medications like dopamine blockers recently.

Structural abnormality or finding on brain MRI suggestive of clinically significant neurological disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Participants undergo initial PET imaging using [18F]PI-2620 to assess tau pathology

Once during single PET imaging

1 visit (in-person)

Follow-up Imaging

Participants from the first year are followed up at 12 months with repeat imaging to investigate temporal changes in tau pathology

12 months

1 visit (in-person)

Data Analysis and Comparison

Comparison of tau binding between different cohorts and imaging systems, and correlation with clinical and biomarker profiles

Ongoing throughout the study

What Are the Treatments Tested in This Trial?

Interventions

• [18F]PI-2620

Trial Overview [18F]PI-2620, a tracer used in PET scans, is being tested to see how well it can detect tau proteins in the brain which are linked to Parkinson's Disease progression.

How Is the Trial Designed?

Group I: Tauopathy Experimental Treatment 1 Intervention

Progressive Supranuclear Palsy (PSP) and Corticobasal Syndrome (CBS)

Group II: Parkinson's Disease (PD) Experimental Treatment 1 Intervention

Sporadic and LRRK2

Group III: Healthy Experimental Treatment 1 Intervention

Healthy participants

Who Is Running the Clinical Trial?

Michael J. Fox Foundation for Parkinson's Research

Lead Sponsor

Trials

117

Recruited

537,000+

Institute for Neurodegenerative Disorders

Collaborator

Trials

49

Recruited

13,000+

Citations

1. ppmi-info.org ppmi-info.org/sites/default/files/docs/029Protocol_NXPI2620PD_12June2025_Final.pdf

Evaluation of Tau-Pathology in Sporadic and LRRK2 ... Investigate the ability of [18F]PI-2620 to detect tau binding in sporadic and LRRK2 PD with taupathies (PSP, CBS) as disease control compared to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10715372/

Tau in Atypical Parkinsonisms: A Meta‐Analysis of in Vivo PET ... [18F]PI‐2620 outperformed first‐generation tracers when comparing PSP‐HC (g = −1.68, 95% CI: −2.05 to −1.30) and CBD‐HC (g = −1.37, 95% CI: −2.25 to −0.49).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07020026

Evaluation of Tau-Pathology in Sporadic and LRRK2 ... The purpose of this study to compare how well [18F] PI-2620, a PET radiotracer targeting Tau protein, bind to brain regions in people with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1053811925000011

Pragmatic algorithm for visual assessment of 4-Repeat ... This study aims to investigate the effectiveness of visual evaluation of [ 18 F]PI-2620 images for diagnosing 4R-tauopathies and to develop a straight-forward ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8495135/

Evaluation of [18F]PI-2620, a second-generation selective ... Standardized uptake value ratio analyses revealed that patients with non-Alzheimer's disease tauopathies had elevated [18F]PI-2620 uptake only in the globus ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7567714/

Early-phase [18F]PI-2620 tau-PET imaging as a surrogate ... Twenty-six subjects were referred with suspected tauopathies or overlapping parkinsonian syndromes (Alzheimer's disease, progressive ...

7. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.28624

Cortical [18F]PI‐2620 Binding Differentiates Corticobasal ... Corticobasal syndrome (CBS) is a rare adult-onset disorder characterized by a combination of cortical signs and movement disorder signs.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07105384

Quantification Tools for a Novel Tau PET Marker in a Rare ... The aim of this clinical trial is to explore the potential of novel 2nd generation tau PET radiotracers as biomarkers in cases suggestive of ...

9. ucns.org ucns.org/common/Uploaded%20files/Continuous%20Certification/2025%20Impact%20of%20Amyloid%20and%20Tau%20PET.pdf

Impact of Amyloid and Tau PET on Changes in Diagnosis ... Assessment of 18F-PI-2620 as a bio- marker in progressive supranuclear palsy. JAMA Neurol. 2020;77(11):1408-1419. 11. Tezuka T, Takahata K, ...