Prodromal Parkinson's Disease
Conditions
Brief summary
This study is a single-center, longitudinal study and will be conducted at the Institute for Neurodegenerative (INDD) Site in New Haven, CT. This study aims to recruit participants from the ongoing Parkinson's Progression Markers Initiative AV-133 Prodromal Imaging sub study \[PPMI 015\] to obtain a second comparison imaging scan. In addition to being imaged with the standard Positron Emission Tomography (PET) camera after the \[18F\]AV133 injection in the PPMI 015 sub study, participants agreeing to a second scan will be imaged with the NeuroEXPLORER (NX) PET camera per this protocol. This study will enroll approximately 25 participants at the INDD site. The dual PET scans will be completed at baseline, 1-and 2- years follow up. Participants may be asked to undergo further longitudinal scans based on the acquired study data. All participants will have longitudinal clinical, biomarker, and genetic data for correlation analyses to imaging data from the PPMI Clinical study.
Interventions
The study will compare the performance of \[18F\]AV133 on both NX and standard PET camera in study participants enrolled at the INDD site in PPMI 015.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Prodromal participant enrolled in the PPMI 015 sub study. 2. Able to provide consent.
Exclusion criteria
a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of tracer uptake between two camera using Standardized Uptake Value ratio | Up to 24 months | To compare \[18F\]AV133 Standardized Uptake Value Ratio (SUVR) in striatal regions and additional relevant regions for images acquired with NX compared to Siemens Biograph in all participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Longitudinal comparison of quantitative signals (SUVR) between two PET cameras | 24 months | To compare the longitudinal regional change in \[18F\]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET |
| Correlation of AV133 longitudinal change to clinical motor change | 24 months | Correlation between longitudinal change in \[18F\]AV133 with NX derived SUVR in different brain regions and change in MDS-UPDRS score reported as correlation coefficient. |
| Correlation of AV133 longitudinal change to clinical cognitive change | 24 months | Correlation between longitudinal change in \[18F\]AV133 with NX derived SUVR in different brain regions and change in Montreal Cognitive Assessment (MoCA) score reported as correlation coefficient. |
| Correlation of AV133 Longitudinal change to CSF biomarker | 24 months | Correlation between longitudinal change in \[18F\]AV133 with NX derived SUVR in different brain regions and change in cerebrospinal fluid (CSF)- seed amplification assay (SAA) level reported as correlation coefficient. |
Countries
United States
Contacts
CONTACTLianne Ramia
CONTACTJessica Dimos
PRINCIPAL_INVESTIGATORKen Marek, MD
Institute for Neurodegenerative Disorders
Outcome results
None listed