Alzheimer's Disease
Conditions
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.
Interventions
DRUGAV-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.
Sponsors
University of Pennsylvania
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clusters based on spatial pattern and extent of T-N Mismatch | 5 years | 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. |
Countries
United States
Contacts
CONTACTJacqueline Lane
PRINCIPAL_INVESTIGATORDavid A. Wolk
University of Pennsylvania Department of Neurology at the Perelman School of Medicine
PRINCIPAL_INVESTIGATORSandhitsu R. Das
University of Pennsylvania Department of Neurology at the Perelman School of Medicine
Outcome results
None listed