ACTIVE_NOT_RECRUITING

Tau PET Imaging in the NACC Study Cohort

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tau PET Imaging in the NACC Study Cohort: Modulators of MTL Subregion Structure and Function in Normal and Pathological Aging

Quick Facts

Study Start:2017-11-22

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03189485

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

David Wolk, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

UPenn

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

David Wolk, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-11-22

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2017-11-22

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Normal Controls
MCI