PET Imaging for Parkinson's Disease

Overseen By Changning Wang, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Massachusetts General Hospital

Must not be taking: Anticoagulants

Disqualifiers: Hypertension, Schizophrenia, Stroke, others

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

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new PET scan tool to evaluate its ability to detect specific brain proteins associated with Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The aim is to understand the tool's effectiveness in both healthy individuals and those with these conditions. Individuals with these conditions who have maintained stable medication for at least 30 days might be suitable candidates. Participants should be comfortable undergoing a brain scan and have someone available to assist in answering questions about their daily activities. As an Early Phase 1 trial, this research seeks to understand the new PET scan tool's function in people, offering participants an opportunity to contribute to groundbreaking advancements in medical imaging.

Will I have to stop taking my current medications?

The trial requires that participants have stable medications for at least 30 days before joining, so you should not stop taking your current medications if they are stable.

What prior data suggests that this PET radiotracer is safe for use in humans?

Research has shown that the treatment C11-SY08 is under study for its use in PET scans to detect certain protein clumps in the brain. These clumps are linked to conditions like Parkinson’s disease, Multiple System Atrophy, and Dementia with Lewy Bodies.

Complete safety information for C11-SY08 is not yet available because this study is in the early stages. Researchers are testing the treatment to determine its safety and how the body reacts to it. Early tests focus on how the treatment moves through the brain and any possible side effects. So far, no major negative effects have been reported, suggesting it might be well-tolerated. However, more information is needed to confirm its safety.

If C11-SY08 had already been approved for any condition, more evidence about its safety would be available. Since it is not, ongoing studies will provide a better understanding of its safety as more participants join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Parkinson's disease aim to manage symptoms through medications that increase dopamine levels or mimic its effects. But C11-SY08 offers a unique approach by using PET imaging to target alpha-synuclein aggregates in the brain, which are thought to play a key role in the progression of Parkinson's. This method allows researchers to visualize and potentially quantify these aggregates, offering insights into the disease's pathology. Researchers are excited because this could lead to earlier and more accurate diagnoses and pave the way for new therapeutic strategies that directly target the underlying causes of Parkinson's rather than just the symptoms.

What evidence suggests that this PET imaging method is effective for evaluating alpha synuclein aggregates in Parkinson's disease?

Research has shown that the PET radiotracer \[11C\]SY08, which participants in this trial will receive, is under study for its ability to image a protein called alpha synuclein in the brain. This protein is linked to conditions like Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies. Early studies aim to understand how \[11C\]SY08 moves and gathers in the brain to help identify these protein clumps. Although limited human data exists, research suggests that \[11C\]SY08 could help distinguish between healthy brains and those affected by these diseases. This could potentially simplify diagnosing and understanding these conditions. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 with Parkinson's Disease, Multiple System Atrophy, or Lewy Body Dementia. Participants must be able to consent, speak English, and have a partner to assist with assessments. They should be on stable medications for at least 30 days.

Inclusion Criteria

You are able to fluently read, speak and comprehend English as we lack the facilities for a comprehensive study of non-English speakers.

My Parkinson's disease is between stages I and IV.

I am willing and able to undergo a PET/MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET Imaging

Participants receive an intravenous bolus injection of [11C]SY08 for brain PET imaging to evaluate brain uptake, distribution, and kinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after PET imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• C11-SY08

Trial Overview [11C]SY08 is being tested as a PET radiotracer in patients with brain alpha-synuclein aggregates and healthy controls. The study will assess how the tracer distributes and moves in the brain after an intravenous injection.

How Is the Trial Designed?

Group I: evaluation of alpha synuclein aggregates in the brain Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Imaging techniques, including FDG PET, (123)I ioflupane SPECT, and amyloid-binding PET, play a crucial role in diagnosing movement disorders with parkinsonian features by helping to differentiate between various syndromes and confirming the loss of dopaminergic neurons.

While no single imaging test can definitively diagnose parkinsonism, a combination of these imaging modalities, along with clinical evaluation, can lead to more accurate diagnoses and better treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Structural and functional imaging in parkinsonian syndromes. Broski, SM., Hunt, CH., Johnson, GB., et al.[2021]

The PET tracer [18F]ACI-12589 shows strong potential for diagnosing α-synuclein-related diseases, particularly Multiple-System Atrophy (MSA), by demonstrating clear binding in affected brain regions in a study of 23 participants.

In vivo imaging with [18F]ACI-12589 effectively distinguishes MSA patients from healthy controls and those with other neurodegenerative disorders, suggesting it could enhance diagnostic accuracy and monitor treatment responses for therapies targeting α-synuclein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The α-synuclein PET tracer [18F] ACI-12589 distinguishes multiple system atrophy from other neurodegenerative diseases. Smith, R., Capotosti, F., Schain, M., et al.[2023]

18F-Dopa PET is a highly sensitive imaging technique that helps diagnose Parkinson's disease by quantifying the loss of dopaminergic fibers, allowing for objective tracking of disease progression.

PET studies reveal that the akinesia (difficulty in movement) associated with Parkinson's is linked to reduced activation in key brain areas responsible for motor preparation, which can be restored through treatments like dopaminergic medication or surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor disturbance and brain functional imaging in Parkinson's disease. Brooks, DJ.[2018]

Fluorodeoxyglucose-PET imaging is highly effective in differentiating between idiopathic Parkinson's disease (IPD) and atypical parkinsonian syndromes, achieving a concordance rate of 91.7% with clinical diagnoses in a study of 136 patients.

Both visual and computer-assisted interpretations of PET scans showed similar diagnostic accuracy, with computer-assisted methods providing an objective evaluation that can be valuable when expert readers are unavailable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential diagnosis of parkinsonian syndromes using F-18 fluorodeoxyglucose positron emission tomography. Tripathi, M., Dhawan, V., Peng, S., et al.[2022]

The study identified a promising PET radiotracer, [11C]4i, which shows high binding affinity to α-synuclein aggregates, making it a potential tool for imaging α-synucleinopathies like multiple system atrophy (MSA) and Parkinson's disease (PD).

In tests, [11C]4i demonstrated significantly higher binding to pathological α-syn aggregates in MSA tissues compared to PD, indicating its potential specificity for MSA and confirming good brain uptake in nonhuman primate studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Brain PET Radiotracer for Imaging Alpha Synuclein Fibrils in Multiple System Atrophy. Kim, HY., Chia, WK., Hsieh, CJ., et al.[2023]

Citations

1. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/pet_alpha_synuclein

PET Imaging of Alpha Synuclein in Neurodegenerative ... We hope to PET image alpha synuclein using [11C]SY08 in a set of patients and healthy controls in order to compare what this protein may look like in the brains ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12155244/

a-synuclein PET Imaging: From Clinical Utility in Multiple ... Data generated from numerous clinical trials have allowed multiple regulatory agencies to accept amyloid brain clearance captured by PET imaging ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/592820

PET Imaging Evaluation of [11C]SY08 The purpose of this study is to evaluate the use of \[11C\]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy ...

4. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-a-potential-pet-radioligand-for-imaging-alpha-synuclein-deposits-in-the-brain

Study to Evaluate a Potential PET Radioligand for Imaging ... The overall goal of this protocol is to evaluate [18F]MNI-1216 (also known as [18F]ACI-12589) as an α-synuclein targeted radiopharmaceutical ...

5. withpower.com withpower.com/trial/early-phase-1-parkinson-disease-10-2023-93af8

PET Imaging for Parkinson's Disease The purpose of this study is to evaluate the use of \[11C\]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The ...

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06098612/

Trial | NCT06098612 The purpose of this study is to evaluate the use of \[11C\]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The ...

7. mdpi.com mdpi.com/2073-4409/14/11/834

a-synuclein PET Imaging: From Clinical Utility in Multiple ... [11C]MK-7337 showed signal retention in the substantia nigra in six of eight sporadic PD patients, but not in healthy controls, while [11C]SY08 showed tracer ...