Tau PET Imaging in the NACC Study Cohort (TPI)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03189485|
Recruitment Status : Recruiting
First Posted : June 16, 2017
Last Update Posted : May 17, 2022
|Condition or disease||Intervention/treatment|
|Normal Controls MCI||Drug: the radiotracer 18F-AV-1451|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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|
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
- 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.
- 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.
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
|Contact: Martha Combs, MSemail@example.com|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Martha Combs, MS 215-662-3084 firstname.lastname@example.org|
|Contact: Jackie Lane, BS 215-662-7057 email@example.com|
|Principal Investigator: David Wolk, MD|
|Principal Investigator:||David Wolk, MD||University of Pennsylvania|