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

NCT05658913 | Recruiting FDA Drug

• 1 other identifier: 850679
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

AV-1451 DRUG

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.

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Enrolled in MPC study (Protocol 850160 at UPenn; Protocol 2022P002447 at MGH).
• Reliable study partner to accompany participant to the PET/CT scan
• 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.

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/CT scan.
• Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
• Have a history of significant ongoing alcohol or substance abuse based on self- report.
• Female participants of child-bearing age will not be able to participate in this study, determined by self-report.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Lane

CONTACT

610-299-1243; Jacqueline.Lane@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 21, 2022
• Study Start: March 14, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)