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The overall objective of this study is to compare the overall pattern of [18F]APN-1607 uptake in subjects with MCI, subjects with AD dementia, and healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alzheimer's Disease | Experimental | AD subjects will undergo PET imaging using [18F]APN-1607. |
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| Mild Cognitive Impairment Due to Alzheimer's Disease | Experimental | MCI subjects will undergo PET imaging using [18F]APN-1607. |
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| Healthy Volunteers | Experimental | Healthy control subjects will undergo PET imaging using [18F]APN-1607. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]APN-1607 | Drug | In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 5-7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of [18F]APN-1607 Uptake Patterns by Regional SUVR Values | Regional [18F]APN-1607 uptake patterns will be assessed in regions of interest (ROIs) and an iROI that are relevant to AD pathology. [18F]APN-1607 uptake patterns identified by regional analysis will be compared among healthy subjects, subjects with MDAD, and subjects with AD dementia. Standard uptake value (SUV) will be calculated for each ROI, and SUVRs will be calculated by normalizing SUV of ROIs to the SUV of relevant reference region. | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | Safety and tolerability profile for the administration of [18F]APN-1607 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs). | 15 months |
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Inclusion Criteria:
Inclusion Criteria for All Subjects:
Inclusion Criteria for Healthy Subjects:
Inclusion Criteria for Subjects with MCI:
Inclusion Criteria for Subjects with AD:
Exclusion Criteria:
Exclusion Criteria for All Subjects:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |