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Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™ | Clinical Trials | Clareo Health

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Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™

Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™ (PPMI Early Imaging)

NCT04507139•Michael J. Fox Foundation for Parkinson's Research

View on ClinicalTrials.gov

Summary

Directly examine whether early (6-month) imaging with DaTscan and \[¹⁸F\] AV-133 will provide an early signal of disease progression in recently diagnosed untreated PD patients.

Detailed Description

The study is a longitudinal, multi-center study to assess progression of DaTscan and \[18F\] AV-133 imaging in PD and Prodromal patients. Participants will be followed for up to 24 months. Approximately 50 early PD participants and 100 Prodromal participants will be recruited from up to 15 sites. Participants will be comprehensively assessed at baseline and follow up according to the Schedule of Activities for the respective cohort. Participants will undergo imaging assessments with DaTscan and \[18F\] AV-133 and clinical (motor, neuropsychiatric and cognitive) assessments. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. A PD participant consented to PPMI Clinical, or, a Prodromal participant confirmed eligible to proceed to PPMI Clinical Baseline visit.
•2. Able to provide informed consent.
•3. Women may not be pregnant, lactating or planning pregnancy during the study.
•* Includes a negative serum pregnancy test prior to Baseline 18F-AV-133 injection.
•* Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of Baseline PET scan.
•* Women participating in the study must be of non-childbearing potential or be using a highly effective method of birth control 14 days prior to until at least 24 hours after the last 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 Screening) 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.

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. Have current clinically significant cardiovascular disease or abnormalities on screening ECG (including but not limited to QTc \> 450 msec).
•3. Are currently taking medications that are known to cause QT- prolongation
•4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Locations (3)

Institute For Neurodegenerative Disorders

New Haven, Connecticut, United States

Boston University Medical Center

Boston, Massachusetts, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 10, 2020

Primary Completion Date

June 1, 2025

Completion Date

June 1, 2025

Last Updated

October 31, 2024

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease

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Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Early Longitudinal Imaging in Parkinson's Progression Markers Initiative Using [¹⁸F] AV-133 and DaTscan™

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

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