Clinical Trials List
Protocol NumberNM_APNPSP
NCT Number(ClinicalTrials.gov Identfier)NCT04541836
2020-01-01 - 2023-12-31
Phase II
Recruiting1
ICD-10G23.0
Hallervorden-Spatz disease
ICD-10G23.1
Progressive supranuclear ophthalmoplegia [Steele-Richardson-Olszewski]
ICD-10G23.2
Striatonigral degeneration
ICD-10G23.8
Other specified degenerative diseases of basal ganglia
ICD-10G23.9
Degenerative disease of basal ganglia, unspecified
ICD-10G90.3
Multi-system degeneration of the autonomic nervous system
ICD-9333.0
Other degenerative diseases of the basal ganglia
Image characteristic and longitudinal follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy
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Trial Applicant
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Sponsor
Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
Linkou Chang Gung Medical Foundation
Chairman/Global PI
林昆儒
Co-Principal Investigator
- Jung-Lung Hsu Division of Neurology
- Yi-Hsin Weng Division of Rehabilitation Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Progressive Supranuclear Palsy
Objectives
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.
Test Drug
18F-PMPBB3 (別名APN-1607, MNI-958, or APN-0000455)
Active Ingredient
[[18F]1-Fluoro-3-((2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dien-1-yl)benzo[d]thiazol-6-y
Dosage Form
injection
Dosage
5±2mCi
Endpoints
Primary Outcome Measures :
Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects [ Time Frame: 5 days ]
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
Secondary Outcome Measures :
To assess disease severity in PSP [ Time Frame: 5 days ]
To assess disease severity in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan
To assess disease progression in PSP [ Time Frame: 1.5 year ]
To assess disease progression in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan
Blood pressure [ Time Frame: 3 hours ]
Systolic and diastolic pressure of subjects will be measured right before injection and after scanning.
Pulse [ Time Frame: 3 hours ]
Pulse will be measured right before injection and after scanning.
Respiration frequency [ Time Frame: 3 hours ]
Respiration frequency will be measured right before injection and after scanning.
Adverse events collection [ Time Frame: 5 days ]
Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects [ Time Frame: 5 days ]
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
Secondary Outcome Measures :
To assess disease severity in PSP [ Time Frame: 5 days ]
To assess disease severity in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan
To assess disease progression in PSP [ Time Frame: 1.5 year ]
To assess disease progression in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan
Blood pressure [ Time Frame: 3 hours ]
Systolic and diastolic pressure of subjects will be measured right before injection and after scanning.
Pulse [ Time Frame: 3 hours ]
Pulse will be measured right before injection and after scanning.
Respiration frequency [ Time Frame: 3 hours ]
Respiration frequency will be measured right before injection and after scanning.
Adverse events collection [ Time Frame: 5 days ]
Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Inclution Criteria
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
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
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
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
The Estimated Number of Participants
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Taiwan
28 participants
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Global
28 participants
