Tau PET Imaging in the NACC Study Cohort

NCT03189485 | Active Not Recruiting FDA Drug

• 2 other identifiers: 825944R01AG055005
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Controls; MCI

Outcome Measures

Primary Outcomes (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.

  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.

  2 years.

Secondary Outcomes (1)

• Determine relationship to clinical, cognitive, and other biomarker data

  2 years.

Study Arms (1)

Normal Controls and MCI

All subjects will receive 18F-AV-1451 PET scan.

Drug: the radiotracer 18F-AV-1451

Interventions

the radiotracer 18F-AV-1451 DRUG

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

Normal Controls and MCI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200 cognitively normal older adults or patients with MCI

You may qualify if:

• Males and females ≥ 60 years of age.
• Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or MCI.
• NACC longitudinal visit must be completed or scheduled to be completed within 6 months of the 18F-AV-1451 TAU PET scan.
• 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.
• An amyloid PET scan completed or scheduled within 12 months of their study scan date
• Women must be post-menopausal or surgically sterile

You may not qualify if:

• Any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
• Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan
• Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• David Wolk, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co Director of the Penn Memory Center

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: June 16, 2017
• Study Start: November 22, 2017
• Primary Completion: October 8, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)