Tau PET/CT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU) (MCP)

To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: AV-1451

Detailed Description

This is a cross-sectional study using the radiotracer AV-1451 to determine the relationship of tau pathology to other biomarker data of MPC participants. All subjects will already have been enrolled in the MPC Study. For the current protocol, participants will provide informed consent before beginning any study procedures. After screening assessments, participants will undergo PET/CT scan imaging with AV-1451.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jacqueline Lane; Phone Number: 610-299-1243; Email: Jacqueline.Lane@pennmedicine.upenn.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2696
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Bradford Dickerson, MD; Phone Number: 617-726-6205; Email: brad.dickerson@mgh.harvard.edu
      • Contact: Erin Krahn; Phone Number: 617-726-6205; Email: ekrahn@mgh.harvard.edu
      • Principal Investigator: Bradford Dickerson, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: David Wolk, MD
      • Contact: Jackie Lane; Phone Number: 610-299-1243; Email: Jacqueline.Lane@pennmedicine.upenn.edu
      • Principal Investigator: Sandhitsu Das, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population includes individuals with a clinical diagnosis of MCI or possible/probably AD

Description

Inclusion Criteria:

1. Enrolled in MPC study (Protocol 850160 at UPenn; Protocol 2022P002447 at MGH).
2. Reliable study partner to accompany participant to the PET/CT scan
3. A brain MRI must be performed within 6 months prior to their study AV-1451 TAU PET/CT scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.

Exclusion Criteria:

1. 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.
2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET/CT scan.
3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
4. Have a history of significant ongoing alcohol or substance abuse based on self- report.
5. Female participants of child-bearing age will not be able to participate in this study, determined by self-report.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clusters based on spatial pattern and extent of T-N Mismatch	We will test the hypotheses that spatial pattern and directionality of deviation in individual subjects of this metric will be correlated with modulatory factors such as non-AD pathology, brain resilience and vulnerability. Specifically, we will use hierarchical clustering to determine groups based on degree and spatial pattern of mismatch between tau PET and cortical thickness measured by MRI. In these groups, we will compare amount of white matter hyperintensities, degree of brain aging, and both cross-sectional and longitudinal cognitive measures, with the primary measure being the Clinical Dementia Rating scale sum of boxes.	5 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: David A. Wolk, University of Pennsylvania Department of Neurology at the Perelman School of Medicine; Principal Investigator: Sandhitsu R. Das, University of Pennsylvania Department of Neurology at the Perelman School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole
• Other Study ID Numbers: 850679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No