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Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)
NCT07265596 · Michael J. Fox Foundation for Parkinson's Research
In plain English
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Official title
Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)
About this study
The Parkinson's Progression Marker Initiative (PPMI) is an observational, international, multi-center study designed to identify PD progression biomarkers both to improve understanding of disease etiology and course and to provide the necessary tools to enhance the likelihood of success of therapeutics studies to slow PD progression (ClinicalTrials.gov Identifier: NCT01141023). A key focus of PPMI is to identify biomarkers during the period when PD neurodegeneration is already present, but symptoms of PD have not yet occurred. This prodromal cohort would enable us to investigate PD biomarker signatures prior to onset of typical symptoms of PD. The study is a longitudinal, multi-center study to assess progression of \[18F\]AV-133 imaging in Prodromal PD participants. The PPMI 015 study will enroll participants from the PPMI Clinical (002) study. Participants will be followed annually for up to 24 months.
Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up.
Participants will undergo \[18F\]AV-133 PET imaging targeting the vesicular monoamine transporter. All participants will undergo an initial \[18F\]AV-133 PET imaging scan at baseline with repeat imaging at 12 months and 24 months.
Eligibility criteria
Inclusion Criteria:
1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
2. Able to provide informed consent.
3. Male or Female (females must meet additional criteria specified below as applicable)
* Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of 18F-AV-133
* Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
* 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.
* Females of childbearing potential must not be pregnant, breastfeeding or lactating.
* Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of PET scan.
Exclusion Criteria:
1. Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.
2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-10-30
Estimated completion: 2027-12
Last updated: 2025-12-05
Interventions
Drug: [18F] AV-133 PET Imaging
Primary outcomes
- • [18F]AV-133 mean rate of change and variability (24 months)
Sponsor
Michael J. Fox Foundation for Parkinson's Research · other
Contacts & investigators
ContactLianne Ramia · contact · LRamia1@indd.org · 203-590-5600
ContactJessica Dimos · contact · jdimos@indd.org · 203-590-5600
InvestigatorKen Marek, MD · principal_investigator, Institute for Neurodegenerative Disorders
All locations (8)
Institute for Neurodegenerative DisordersRecruiting
New Haven, Connecticut, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Toronto Western HospitalNot Yet Recruiting
Toronto, Ontario, Canada
Philipps-University of MarburgNot Yet Recruiting
Hessen, Germany
Tel Aviv Sourasky Medical CenterNot Yet Recruiting
Tel Aviv, Israel
Radboud UniversityNot Yet Recruiting
Nijmegen, Gelderland, Netherlands
Queen Mary University of LondonRecruiting
London, Britain, United Kingdom
Newcastle UniversityRecruiting
Newcastle upon Tyne, Tyne and Wear, United Kingdom