TSPO-PET for Neuroinflammation in Parkinson's Disease

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET (Positron Emission Tomography) ligand [18F]DPA-714 in participants enrolled in the UAB Neuroinflammation in PD study. The PET tracer [18F]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of [18F]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing Neuroinflammation in PD study. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with [18F]DPA-714-PET/MRI.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham

Criteria

Inclusion Criteria:

1. Enrollment in the UAB Neuroinflammation in PD study under the separate UAB approved research protocol IRB-300000690.

2. Negative urine or serum hCG test within 2 days of [18F]DPA-714-PET administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

3. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.

Exclusion Criteria:

1. Meets any exclusion criteria for the UAB Neuroinflammation in PD study.

2. Contraindication to MRI and/or PET imaging

3. Inability to participate in the imaging studies due to severity of PD or other medical comorbidities.

4. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. -