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

NCT ID: NCT05658913

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2029-12-31

Brief Summary

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.

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.

Conditions

Alzheimer's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

AV-1451

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.

Intervention Type: DRUG

Other Intervention Names

7-(6-[18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

David Wolk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A. Wolk

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Department of Neurology at the Perelman School of Medicine

Sandhitsu R. Das

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Department of Neurology at the Perelman School of Medicine

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacqueline Lane

Role: CONTACT

Jacqueline.Lane@pennmedicine.upenn.edu

610-299-1243

Facility Contacts

Bradford Dickerson, MD

Role: primary

brad.dickerson@mgh.harvard.edu

617-726-6205

Erin Krahn

Role: backup

ekrahn@mgh.harvard.edu

617-726-6205

Jackie Lane

Role: primary

Jacqueline.Lane@pennmedicine.upenn.edu

610-299-1243

Other Identifiers

850679

Identifier Type: -

Identifier Source: org_study_id