NCT Number: NCT07809438
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
New Haven, Connecticut, 06510, United States
Location status: Recruiting
Kristen Hagwell Clinical Research Nurse II, RN
CONTACT
Mackenzee George Clinical Research Coordinator II
CONTACT
Neha Prakash, MBBS
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a) Any medical or psychiatric condition or lab abnormality that precludes participation per investigators judgement.
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.
Time frame: 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
Time frame: 24 months
To compare the longitudinal regional change in [18F]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Jessica Dimos
CONTACT
Lianne Ramia
CONTACT
Michael J. Fox Foundation for Parkinson's Research
Other
A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography (PET) Camera Using [18F]AV-133 in Prodromal Parkinson's Disease [Dual PET AV133 in Prodromal PD]
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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