PET Imaging for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

Overseen by Jonathan McConathy, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: High radiation exposure, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should not have started symptomatic treatment for Parkinson's Disease at the time of enrollment or during the first 2 years of participation.

Is [18F]DPA714 safe for use in humans?

The research does not provide specific safety data for [18F]DPA714 in humans, but it has been used in studies to monitor brain inflammation in conditions like Alzheimer's disease and Parkinson's disease, suggesting it is considered safe enough for research purposes. ^{1 2 3 4 5}

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

PET imaging for Parkinson's disease is unique because it uses special imaging techniques to visualize brain activity and inflammation, helping to diagnose and monitor the disease, rather than directly treating symptoms like traditional medications. ^{1 6 7 8 9}

Research Team

Jonathan McConathy, MD, PhD

Principal Investigator

University of Alabama at Birmingham

David Standaert, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals with early-stage or prodromal Parkinson's Disease, as well as healthy volunteers. Participants will be monitored over a 24-month period to track changes in their condition.

Inclusion Criteria

I have Parkinson's and haven't started treatment for symptoms yet or within the first 2 years of joining the study.

Able to provide informed consent

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 oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable

Exclusion Criteria

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

Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations, during the past year

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline TSPO-PET imaging to measure regional brain TSPO levels

1 visit

1 visit (in-person)

Longitudinal Imaging

Participants undergo TSPO-PET imaging to assess changes in neuroinflammation 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

4 weeks

Treatment Details

Interventions

• [F-18]DPA714 (Virus Therapy)

Trial Overview [18F]DPA-714, an imaging compound, is being tested through IV administration to see how it binds in the brain of those with Parkinson's compared to healthy people and how this binding changes over two years.

Participant Groups

Group I: Prodromal and manifest (PD) participants Experimental Treatment 1 Intervention

Group II: Healthy participants Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UAB Birmingham, AL

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1677

Patients Recruited

2,458,000+

Michael J. Fox Foundation for Parkinson's Research

Collaborator

Trials

117

Patients Recruited

537,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. Lavisse, S., Goutal, S., Wimberley, C., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]AV-1451 binding to neuromelanin in the substantia nigra in PD and PSP. Coakeley, S., Cho, SS., Koshimori, Y., et al.[2022]

The study developed a molecular imaging probe, [18F]DPA714, which effectively targets the 18-kDa translocator protein (TSPO) to monitor microglia activation and neuroinflammation in an Alzheimer's disease mouse model, showing a significant increase in uptake in affected brain regions compared to control mice.

Quantitative PET imaging revealed that [18F]DPA714 uptake was significantly higher in the cortex and hippocampus of APP/PS1 mice at 12-13 and 15-16 months of age, indicating its potential utility in determining optimal timing for anti-inflammatory therapies in Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PET Imaging for Dynamically Monitoring Neuroinflammation in APP/PS1 Mouse Model Using [18F]DPA714. Hu, W., Pan, D., Wang, Y., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of dopamine transporters in Parkinson disease: a meta-analysis of 18 F/123 I-FP-CIT studies. Kong, Y., Zhang, C., Liu, K., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A revisit to quantitative PET with 18F-FDOPA of high specific activity using a high-resolution condition in view of application to regenerative therapy. Akamatsu, G., Ohnishi, A., Aita, K., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular Imaging of Neurodegenerative Parkinsonism. Frey, KA., Bohnen, NILJ.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

VMAT2 imaging agent, D6-[18F]FP-(+)-DTBZ: Improved radiosynthesis, purification by solid-phase extraction and characterization. Zhao, R., Zha, Z., Yao, X., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Significance of F-18 FP-CIT Dual Time Point PET Imaging in Idiopathic Parkinson's Disease. Oh, JK., Yoo, ID., Seo, YY., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. England pubmed.ncbi.nlm.nih.gov

Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

[18F]AV-1451 binding to neuromelanin in the substantia nigra in PD and PSP. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

PET Imaging for Dynamically Monitoring Neuroinflammation in APP/PS1 Mouse Model Using [18F]DPA714. [2020]

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

Imaging of dopamine transporters in Parkinson disease: a meta-analysis of 18 F/123 I-FP-CIT studies. [2021]

5. Japan pubmed.ncbi.nlm.nih.gov

A revisit to quantitative PET with 18F-FDOPA of high specific activity using a high-resolution condition in view of application to regenerative therapy. [2017]

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

Molecular Imaging of Neurodegenerative Parkinsonism. [2021]

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

VMAT2 imaging agent, D6-[18F]FP-(+)-DTBZ: Improved radiosynthesis, purification by solid-phase extraction and characterization. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Clinical Significance of F-18 FP-CIT Dual Time Point PET Imaging in Idiopathic Parkinson's Disease. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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