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This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553). | |
| Treatment Group | Experimental | Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-AV-1451 | Drug | Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection. Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment.. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in tau PET Standardized Uptake Value (SUVR) | A PET Standardized Uptake Value (SUV) is measured by calculating the ratio of the radioactivity concentration within a specific region of interest (ROI) on a PET scan, divided by the injected dose of the radiotracer per unit of the patient's body weight. The calculated Standardized Uptake Value (SUVR) is reported as a single number, with higher values indicating greater tracer uptake in the target region relative to the reference region | Baseline, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects to develop amyloid-related imaging abnormalities (ARIA) | ARIA is defined as edema (parenchymal edema or sulcal effusion, ARIA-E) and hemorrhage (microhemorrhages and superficial siderosis, ARIA-H). ARIA is detected on the patient's routine clinical brain MRIs. | 18 months |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Petrice Cogswell, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D008224 | Lymphoma, Follicular |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
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|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |