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PPMI Tau PET Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04906590
Recruitment Status : Completed
First Posted : May 28, 2021
Last Update Posted : April 21, 2023
Sponsor:
Collaborator:
Institute for Neurodegenerative Disorders
Information provided by (Responsible Party):
Michael J. Fox Foundation for Parkinson's Research

Study Description
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Brief Summary:
The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) will evaluate if [18F] PI-2620 facilitates better understanding of Tau deposition in the brain in Parkinson's disease (PD).

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: [18F] PI-2620 Phase 2

Detailed Description:
The Assessment of Brain Tau Burden in Participants with Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging) is a companion study to the Parkinson's Progression Markers Initiative Clinical protocol (PPMI-002; NCT04477785). After consenting to the PPMI Clinical protocol, participants interested in completing an additional scan under this study will be asked to complete consent, additional activities, and one [18F]PI-2620 PET imaging scan as part of this study. Enrollment in the PPMI Tau PET Imaging companion study will facilitate comparison of tau deposition to clinical, imaging, blood and CSF tau already acquired in these PPMI participants under the PPMI Clinical protocol. The primary goal of this imaging study is to test whether positron emission tomography (PET) with [18F] PI-2620 can visualize in vivo brain tau deposition in participants with PD. The secondary goal is to evaluate tau deposition in PD LRRK2 mutation carriers given recent data that tau pathology may be present in those individuals.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Brain Tau Burden in Participants With Parkinson's Disease in the PPMI Study (PPMI Tau PET Imaging)
Actual Study Start Date : August 30, 2021
Actual Primary Completion Date : January 30, 2023
Actual Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Drug
All participants will receive PI-2620.
 Drug: [18F] PI-2620
Evaluation of the radiopharmaceutical imaging agent PI-2620 in detecting TAU brain burden.


Outcome Measures
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Primary Outcome Measures :
  1. Determination of [18F]PI-2620 standard uptake value ratio (SUVR) targeting brain tau deposition in comparison between Parkinson disease and healthy control participants. [ Time Frame: 90 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrolled in PPMI Clinical protocol
  • Able to provide informed consent

  • 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]PI-2620.
    • 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.
    • Females of childbearing potential have a negative urine pregnancy test prior to [18F]PI-2620 injection on day of PET scan.

Exclusion Criteria:

  • Exposure to an effective radiation dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines during the past year.
  • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04906590


Locations
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United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Michael J. Fox Foundation for Parkinson's Research
Institute for Neurodegenerative Disorders
More Information
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Responsible Party: Michael J. Fox Foundation for Parkinson's Research
ClinicalTrials.gov Identifier: NCT04906590    
Other Study ID Numbers: PPMI-008
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases