A Comparative Performance Study Between High and Standard Resolution Positron Emission Tomography Camera Using [18F] AV-133 in Prodromal Parkinson's Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMichael J. Fox Foundation for Parkinson's Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prodromal participant enrolled in the PPMI 015 sub study.

Able to provide consent.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F] AV-133 PET Imaging

    Drug

    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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Prodromal Parkinson's disease (PD)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of tracer uptake between two camera using Standardized Uptake Value ratio

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
Up to 24 months

Secondary outcomes

1

Longitudinal comparison of quantitative signals (SUVR) between two PET cameras

To compare the longitudinal regional change in \[18F\]AV133 SUVR in images acquired with NX PET and Siemens Biograph PET

Time frame
24 months
2

Correlation of AV133 longitudinal change to clinical motor change

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
3

Correlation of AV133 longitudinal change to clinical cognitive change

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
4

Correlation of AV133 Longitudinal change to CSF biomarker

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

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