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

NCT04251130 | Active Not Recruiting FDA Drug

• 1 other identifier: 833864
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (4)

• Correlation between PI-2620 SUVR and MTL subregion thickness

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

  Baseline

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

  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.

  Baseline

• Correlation between longitudinal PI-2620 SUVR and MTL subregion thickness

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

  18-24 months

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

  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.

  18-24 months

Study Arms (2)

Cognitively Normal Older Adults

Subjects will receive an IV bolus injection of approximately 5 mCi ± 20% of \[18F\]PI-2620. All subjects will undergo a 30-minute brain PET/CT scan performed starting at approximately 45 minutes' post injection of \[18F\]PI-2620. A low-dose CT scan will be acquired according to standard PET/CT imaging procedures to be used for attenuation correction. All images will be reconstructed using standard reconstruction techniques

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

Mild Cognitively Impaired Older Adults or Older Adults with Alzheimer's Disease

Subjects will receive an IV bolus injection of approximately 5 mCi ± 20% of \[18F\]PI-2620. All subjects will undergo a 30-minute brain PET/CT scan performed starting at approximately 45 minutes' post injection of \[18F\]PI-2620. A low-dose CT scan will be acquired according to standard PET/CT imaging procedures to be used for attenuation correction. All images will be reconstructed using standard reconstruction techniques

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

Interventions

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.

Also known as: [18F]PI-2620

Cognitively Normal Older Adults; Mild Cognitively Impaired Older Adults or Older Adults with Alzheimer's Disease

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

Adults cognitively normal or Mild Cognitive Impairment (MCI) or Alzheimer's Disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Pennsylvania, School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

((18)F)PI-2620

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Wolk, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 31, 2020
• Study Start: March 11, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

US (1)