PET Imaging for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Massachusetts General Hospital

Must not be taking: Anticoagulants

Disqualifiers: Hypertension, Schizophrenia, Stroke, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall goal of the proposed research is to evaluate the use of \[11C\]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls. 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 specific aims of the current study are: 1. To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in healthy individuals. 2. To determine brain uptake, distribution, and kinetics of \[11C\]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. 3. To determine human dosimetry of \[11C\]SY08 in healthy individuals An intravenous bolus injection of \[11C\]SY08 will be administered per subject for brain PET 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.

How does PET imaging for Parkinson's disease differ from other treatments?

PET imaging for Parkinson's disease is unique because it uses a special tracer to visualize alpha-synuclein, a protein involved in the disease, which helps in distinguishing Parkinson's from other similar disorders. This approach is different from traditional treatments that focus on managing symptoms rather than improving diagnosis. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• C11-SY08 (Radiopharmaceutical)

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.

Participant Groups

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+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Structural and functional imaging in parkinsonian syndromes. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The α-synuclein PET tracer [18F] ACI-12589 distinguishes multiple system atrophy from other neurodegenerative diseases. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Differential diagnosis of parkinsonian syndromes using F-18 fluorodeoxyglucose positron emission tomography. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

A Novel Brain PET Radiotracer for Imaging Alpha Synuclein Fibrils in Multiple System Atrophy. [2023]