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Tau PET Imaging in the NACC Study Cohort (TPI)

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ClinicalTrials.gov Identifier: NCT03189485
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : May 17, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
David Wolk, University of Pennsylvania

Brief Summary:
The purpose of this study is to measure the amount of a protein in the brain known as tau using an imaging procedure called Positron Emission Tomography (PET/CT). 18F-AV-1451 is a specialized radioactive PET imaging agent that is able to detect the presence of tau in the brain. In this study, the investigator will use the 18F-AV-1451 to capture images of tau in the brain. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of very early Alzheimer's disease.

Condition or disease Intervention/treatment
Normal Controls MCI Drug: the radiotracer 18F-AV-1451

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Tau PET Imaging in the NACC Study Cohort: Modulators of MTL Subregion Structure and Function in Normal and Pathological Aging
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Normal Controls and MCI
All subjects will receive 18F-AV-1451 PET scan.
Drug: the radiotracer 18F-AV-1451
Subjects will receive a single IV bolus injection target dose of approximately 370 MBq (10 mCi ± 20%) of 18F-AV-1451 At approximately 75 minutes post dose, scanning will begin. An approximately 30-minute acquisition (six 5 minute intervals) will be performed




Primary Outcome Measures :
  1. Examine uptake of 18F-AV-1451 in the medial temporal lobe (MTL) and its relationship with high-resolution structural and functional MRI measures of MTL subregions. [ Time Frame: 2 years. ]
    Specific analyses will include quantitative measures of 18F-AV-1451 within the medial temporal lobe (MTL) and its relationship to volume and thickness of MTL subregions measured with high-resolution MRI.


Secondary Outcome Measures :
  1. Determine relationship to clinical, cognitive, and other biomarker data [ Time Frame: 2 years. ]
    Correlation and regression analyses will be performed to determine relationships between 18F-AV-1451 and cross-sectional and longitudinal measures acquired as part of each individuals participation in the NACC longitudinal cohort study, including, but not limited to, MRI imaging, neurocognitive testing, demographic information, genetic data, and clinical outcomes.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 cognitively normal older adults or patients with MCI
Criteria

Inclusion Criteria:

  1. Males and females ≥ 60 years of age.
  2. Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or MCI.
  3. NACC longitudinal visit must be completed or scheduled to be completed within 6 months of the 18F-AV-1451 TAU PET scan.
  4. A brain MRI must be performed within 12 months prior to their study scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T and/or 7 Tesla high-resolution imaging of medial temporal lobe structures.
  5. An amyloid PET scan completed or scheduled within 12 months of their study scan date
  6. Women must be post-menopausal or surgically sterile

Exclusion Criteria:

  1. Any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan
  3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
  4. Have current clinically significant cardiovascular disease .Have a history of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported

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): NCT03189485


Contacts
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Contact: Martha Combs, MS 215-615-3084 martha.combs@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
UPenn Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Martha Combs, MS    215-662-3084    martha.combs@pennmedicine.upenn.edu   
Contact: Jackie Lane, BS    215-662-7057    jacquline.lane@pennmedicine.upenn.edu   
Principal Investigator: David Wolk, MD         
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Investigators
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Principal Investigator: David Wolk, MD University of Pennsylvania
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Responsible Party: David Wolk, Co Director of the Penn Memory Center, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03189485    
Other Study ID Numbers: 825944
R01AG055005 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No