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This study is to evaluate the efficacy and safety of [18F]-APN-1607 Injection in PET imaging for detecting AD-related cognitive impairment.
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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 | Other | 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 | Participants will receive a single intravenous injection of 5-7 mCi of [18F]-APN-1607, and a whole-body PET/CT scan will begin immediately after administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of visual reading results of [18 F]-APN-1607 injection PET imaging in detecting tau NFTs(Neurofibrillary Tangles) | Sensitivity and specificity of PET imaging visual interpretation results of [ 18 F]-APN-1607 injection compared with true standards | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of [18 F]-APN-1607 Uptake Patterns by Regional SUVR Values and the capability in differentiating different groups | Based on [18F]-APN-1607 PET, the sensitivity and specificity of area under the curve (AUC) with semi-quantitative analysis of standardized uptake values (SUVR) of brain regions of comprehensive interest (iROI) in the brain to distinguish HV subjects from AD-related cognitive impairment subjects (MCI+AD), as well as MCI subjects from AD subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| 15 months |
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | Safety for theadministration of [18F]APN-1607 and PET scanning is measured by number of participants with Adverse events / Serious adverse events | 15 months |
| Huashan Hospital of Fudan University | Recruiting | Shanghai | Province | 201199 | China |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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