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

ConditionAlzheimer's Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-120

SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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.

Time frame

5 years

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov

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