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NCT Number: NCT04251130

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania, School of Medicine

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females ≥ 60 years of age.
  • Part of the NACC longitudinal cohort (IRB# 068200) of the PMC/ADCC with consensus conference designation of cognitively normal or Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) Possible or Probable.
  • NACC longitudinal visit completed or scheduled within 6 months before or after enrollment 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 be performed 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 performed or scheduled within 6 months before or after the [18F]PI-2620 PET scan. Scan should be of adequate research quality, including 3 Tesla and/or 7 Tesla high-resolution imaging of MTL structure.

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 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 a history of significant or ongoing alcohol abuse or substance abuse or dependence 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)

Treatment and study plan

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

Drug

A small molecule aimed for binding and PET-imaging of aggregated tau protein in the human brain.

Other names: [18F]PI-2620

Primary outcomes

  1. Correlation between PI-2620 SUVR and MTL subregion thickness

    Time frame: Baseline

    Correlation between cross-sectional PI-2620 standard uptake value ratio (SUVR) and MTL subregion thickness (mm) in both controls and MCI/AD.

  2. Interaction between PI-2620 SUVR and amyloid status prediction of MTL subregion thickness

    Time frame: Baseline

    Interaction between cross-sectional PI-2620 standard uptake value ratio (SUVR) and amyloid status for prediction of MTL subregion thickness (mm) in both controls and MCI/AD.

  3. Correlation between longitudinal PI-2620 SUVR and MTL subregion thickness

    Time frame: 18-24 months

    Correlation between longitudinal PI-2620 standard uptake value ratio (SUVR) and MTL subregion thickness (mm) in both controls and MCI/AD.

  4. Interaction between longitudinal PI-2620 SUVR and amyloid status for prediction of MTL subregion thickness

    Time frame: 18-24 months

    Interaction between longitudinal PI-2620 standard uptake value ratio (SUVR) and amyloid status for prediction of MTL subregion thickness (% annual change) in both controls and MCI/AD.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2020
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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