Linking Tau PET to Medial Temporal Lobe Subregions With High Resolution MRI

Last updated: September 4, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Memory Loss

Mild Cognitive Impairment

Dementia

Treatment

2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine

Clinical Study ID

NCT04251130
833864
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The investigators will conduct a tau PET scan in cognitively normal older adults and patients with Mild Cognitive Impairment (MCI), enrolled in the National Alzheimer's Coordinating Center (NACC) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females ≥ 60 years of age.

  • Part of the NACC longitudinal cohort (IRB# 068200) of the PMC/ADCC with consensusconference designation of cognitively normal or Mild Cognitive Impairment (MCI) orAlzheimer's Disease (AD) Possible or Probable.

  • NACC longitudinal visit completed or scheduled within 6 months before or afterenrollment in this study.

  • Women must be post-menopausal or surgically sterile.

  • An amyloid PET scan, completed as a part of the NACC protocol (IRB# 825943), must beperformed or scheduled within 12 months before or after the [18F]PI-2620 PET scan.

  • A brain MRI, completed as a part of NACC protocol (IRB# 068200), must be performedor scheduled within 6 months before or after the [18F]PI-2620 PET scan. Scan shouldbe of adequate research quality, including 3 Tesla and/or 7 Tesla high-resolutionimaging of MTL structure.

Exclusion

Exclusion Criteria:

  • Have 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 thatis likely to interfere with analysis of the PET scan.

  • Inability to tolerate or contraindication to imaging procedures in the opinion of aninvestigator or treating physician.

  • Have a history of significant or ongoing alcohol abuse or substance abuse ordependence based on medical record review or self-reported.

The inclusion / exclusion criteria will be ascertained through self-report in conjunction with any medical history available through the participant's medical or research records (EPIC or the ADC database)

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: 2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine
Phase:
Study Start date:
March 11, 2020
Estimated Completion Date:
January 31, 2027

Study Description

This is a cross-sectional and longitudinal study using the radiotracer [18F]-PI-2620 to determine the relationship of tau pathology to both cross-sectional and longitudinal clinical and biomarker data of NACC cohort participants who are Cognitively Normal or MCI. All subjects will already be part of the longitudinal cohort study, known as the "NACC" cohort, of the PMC/ADC (protocol 068200). Participants will provide informed consent for this protocol before beginning any study procedures. After screening assessments, participants will undergo PET scan imaging with [18F]PI-2620. There will be one follow-up [18F]PI-2620 PET scan approximately 18 +/- 6 months after bas eline scan.

Connect with a study center

  • University of Pennsylvania, School of Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania, School of Medicine

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

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