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Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease patients and healthy subjects.
Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably Alzheimer's dementia patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| F-18 THK-5351 | Experimental | F-18 THK-5351 imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 THK-5351 | Drug | Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably AD patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measures are to evaluate the dosimetry of novel radiotracer F-18 THK-5351 in human. | Time-integrated activity in each organ will be calculated by trapezoidal integration of the first 45 min of the organ's time-activity curve, followed by a single-exponential fit to the remaining data points (based on the 4 whole-body images) extrapolate to infinity, all base on non-decay-corrected data.Residence times will be obtained by dividing the time-integrated activity by the injected amount of activity. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal scanning time for brain imaging using F-18 THK-5351. | PET data will be acquired using SIMENS PET/CT or PET/MRI scanner with an axial field of view of 15.7cm. For PET/CT protocol, a 50-min dynamic brain PET scan (6x10s, 4x60s, 5x180s, 6x300s) will be started simultaneously with the injection of 10mCi of F-18 THK-5351 after a low-dose CT scan for patient positioning and attenuation correction. |
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Healthy Inclusion Criteria:
Patients with AD Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28336780 | Derived | Hsiao IT, Lin KJ, Huang KL, Huang CC, Chen HS, Wey SP, Yen TC, Okamura N, Hsu JL. Biodistribution and Radiation Dosimetry for the Tau Tracer 18F-THK-5351 in Healthy Human Subjects. J Nucl Med. 2017 Sep;58(9):1498-1503. doi: 10.2967/jnumed.116.189126. Epub 2017 Mar 23. |
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|
| One year |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| 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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