Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy

Conditions
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Progressive Supranuclear Palsy

Intervention / Treatment
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* Diagnostic Test: 18F-PMPBB3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Patients fulfill the criteria of NINDS-SPSP clinical criteria for the diagnosis of PSP as possible or probably PSP, and healthy volunteer with no clinically relevant finding on physical examination at screening visit. Age range 20-90 years Exclusion Criteria: Implantation of metal devices including cardiac pacemaker, intravascular metal devices. Major systemic diseases including coronary arterial disease, heart failure, uremia, hepatic failure, prominent strokes, acute myocardial infarction, poorly controlled diabetes, previous head injury, intracranial operation, hypoxia, sepsis or severe infectious diseases Major psychiatric disorders, drug or alcohol abuse and major depression Pregnant women or breast- feeding women

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy control<br>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. | Diagnostic Test: 18F-PMPBB3<br>* single intravenous injection 5mCi 18F-PMPBB3 per scan<br>* Other names: 18F-APN-0000455;|
| PSP<br>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. | Diagnostic Test: 18F-PMPBB3<br>* single intravenous injection 5mCi 18F-PMPBB3 per scan<br>* Other names: 18F-APN-0000455;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tauopathy, Progressive Supranuclear Palsy, F-18 APN1607 PET, F-18 PMPBB3 PET