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The study will enroll 20 PSP and 8 normal subjects with complete neurological examination, 18F-PMPBB3 (APN-1607) PET and MRI assessment. To explore: (1) whether 18F-PMPBB3 (APN-1607) can detect the 4R tau protein in the brain of PSP patients; (2) whether 18F-PMPBB3 (APN-1607) can distinguish the clinical characteristics of PSP; (3) Whether the distribution of tau deposition is related to disease severity, progression, and prognosis.
Progressive supranuclear palsy (PSP), also known as Steele-Richardson-Olszewski syndrome, has a similar incidence in men and women. The pathophysiology of PSP is remaining unclear, but it is known to be related to the abnormal accumulation of 4R tau protein in the brain. Recently, new generation of novel radiotracer 18F-PMPBB3 (APN-1607), which can be labeled with 4R PHF-tau without significant off-target binding, has been successfully developed. The study will enroll 20 PSP and 8 normal subjects with complete neurological examination, 18F-PMPBB3 (APN-1607) PET and MRI assessment. To explore: (1) whether 18F-PMPBB3 (APN-1607) can detect the 4R tau protein in the brain of PSP patients; (2) whether 18F-PMPBB3 (APN-1607) can distinguish the clinical characteristics of PSP; (3) Whether the distribution of tau deposition is related to disease severity, progression, and prognosis. The research results will help to understand the potential of 18F-PMPBB3 (APN-1607) as a biomarker for diagnosis and therapeutic assessment tool for progressive nuclear paralysis as well as other tau proteinopathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy control | healthy volunteer with no clinically relevant finding on physical examination at screening visit will receive one baseline 18F-PMPBB3 tau PET scan, and another follow up scan 1.5yr later. |
| |
| PSP | Patients fulfill the criteria of NINDS-SPSP clinical criteria for the diagnosis of PSP "as possible" or "probably" PSP will receive one baseline 18F-PMPBB3 tau PET scan, and another follow up scan 1.5yr later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-PMPBB3 | Diagnostic Test | single intravenous injection 5mCi 18F-PMPBB3 per scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects | Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects Measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess disease severity in PSP | To assess disease severity in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan | 5 days |
| To assess disease progression in PSP | To assess disease progression in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan |
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Inclusion Criteria:
Exclusion Criteria:
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PSP patient will be enrolled from primary care clinic or hospital, control (healthy subjects) will be enrolled from community.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun-Ju Lin, MD PhD | Contact | 886-3-3281200 | 2625 | kunjulin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital,Linkou | Recruiting | Taoyuan City | Guishan Dist | 333 | Taiwan |
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| ID | Term |
|---|---|
| D013494 | Supranuclear Palsy, Progressive |
| D024801 | Tauopathies |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 1.5 year |
| Blood pressure | Systolic and diastolic pressure of subjects will be measured right before injection and after scanning. | 3 hours |
| Pulse | Pulse will be measured right before injection and after scanning. | 3 hours |
| Respiration frequency | Respiration frequency will be measured right before injection and after scanning. | 3 hours |
| Adverse events collection | Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed. | 5 days |
| D009069 | Movement Disorders |
| D009886 | Ophthalmoplegia |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D019636 | Neurodegenerative Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |