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

  • STATUS
    Recruiting
  • End date
    Jan 27, 2022
  • participants needed
    50
  • sponsor
    Michael J. Fox Foundation for Parkinson's Research
Updated on 27 August 2021
positron emission tomography
datscan

Summary

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

Description

A multi-center study to assess progression of DaTscan and [F] AV-133 imaging in PD patients. Participants will be followed for at least 18 months. Approximately 50 PD participants will be recruited from up to 5 sites. All participants will be comprehensively assessed at baseline and every six months thereafter. Participants will undergo imaging assessments with DaTscan and [F] AV-133, clinical (motor, neuropsychiatric and cognitive) assessments, as well as biospecimen collection for biomic analysis. Data will be collected by each site under uniformly established protocols and data will be stored and analyzed at designated core facilities.

Details
Condition Parkinson's disease, parkinson's, parkinson disease
Clinical Study IdentifierNCT04507139
SponsorMichael J. Fox Foundation for Parkinson's Research
Last Modified on27 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Enrolled in PPMI 2.0 Clinical protocol
Able to provide informed consent
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

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