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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The investigators will conduct a tau PET scan in cognitively normal older adults and patients with Mild Cognitive Impairment (MCI), enrolled in the National Alzheimer's Coordinating Center (NACC) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).
This is a cross-sectional and longitudinal study using the radiotracer [18F]-PI-2620 to determine the relationship of tau pathology to both cross-sectional and longitudinal clinical and biomarker data of NACC cohort participants who are Cognitively Normal or MCI. All subjects will already be part of the longitudinal cohort study, known as the "NACC" cohort, of the PMC/ADC (protocol 068200). Participants will provide informed consent for this protocol before beginning any study procedures. After screening assessments, participants will undergo PET scan imaging with [18F]PI-2620. There will be one follow-up [18F]PI-2620 PET scan approximately 18 +/- 6 months after bas eline scan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitively Normal Older Adults | Subjects will receive an IV bolus injection of approximately 5 mCi ± 20% of [18F]PI-2620. All subjects will undergo a 30-minute brain PET/CT scan performed starting at approximately 45 minutes' post injection of [18F]PI-2620. A low-dose CT scan will be acquired according to standard PET/CT imaging procedures to be used for attenuation correction. All images will be reconstructed using standard reconstruction techniques |
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| Mild Cognitively Impaired Older Adults or Older Adults with Alzheimer's Disease | Subjects will receive an IV bolus injection of approximately 5 mCi ± 20% of [18F]PI-2620. All subjects will undergo a 30-minute brain PET/CT scan performed starting at approximately 45 minutes' post injection of [18F]PI-2620. A low-dose CT scan will be acquired according to standard PET/CT imaging procedures to be used for attenuation correction. All images will be reconstructed using standard reconstruction techniques |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine | Drug | A small molecule aimed for binding and PET-imaging of aggregated tau protein in the human brain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between PI-2620 SUVR and MTL subregion thickness | Correlation between cross-sectional PI-2620 standard uptake value ratio (SUVR) and MTL subregion thickness (mm) in both controls and MCI/AD. | Baseline |
| Interaction between PI-2620 SUVR and amyloid status prediction of MTL subregion thickness | Interaction between cross-sectional PI-2620 standard uptake value ratio (SUVR) and amyloid status for prediction of MTL subregion thickness (mm) in both controls and MCI/AD. | Baseline |
| Correlation between longitudinal PI-2620 SUVR and MTL subregion thickness | Correlation between longitudinal PI-2620 standard uptake value ratio (SUVR) and MTL subregion thickness (mm) in both controls and MCI/AD. | 18-24 months |
| Interaction between longitudinal PI-2620 SUVR and amyloid status for prediction of MTL subregion thickness | Interaction between longitudinal PI-2620 standard uptake value ratio (SUVR) and amyloid status for prediction of MTL subregion thickness (% annual change) in both controls and MCI/AD. | 18-24 months |
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Inclusion Criteria:
Exclusion Criteria:
The inclusion / exclusion criteria will be ascertained through self-report in conjunction with any medical history available through the participant's medical or research records (EPIC or the ADC database)
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Adults cognitively normal or Mild Cognitive Impairment (MCI) or Alzheimer's Disease.
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| Name | Affiliation | Role |
|---|---|---|
| David Wolk, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000710692 | ((18)F)PI-2620 |
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