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

• Conditions: Progressive Supranuclear Palsy
• Interventions: Diagnostic Test: 18F-PMPBB3

• Registration Number: NCT04541836
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-06-15
• Status Verified: 2020-08
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-08
• Last Update Submitted: 2020-09-08
• Study First Posted: 2020-09-09
• Last Update Posted: 2020-09-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. 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.
3. Age range 20-90 years

Exclusion Criteria

1. Implantation of metal devices including cardiac pacemaker, intravascular metal devices.
2. 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
3. Major psychiatric disorders, drug or alcohol abuse and major depression
4. Pregnant women or breast- feeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSP	18F-PMPBB3	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.
healthy control	18F-PMPBB3	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.

Primary Outcome Measures

Name	Time	Method
Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects	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

Name	Time	Method
To assess disease progression in PSP	1.5 year	To assess disease progression in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan
Blood pressure	3 hours	Systolic and diastolic pressure of subjects will be measured right before injection and after scanning.
Adverse events collection	5 days	Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Pulse	3 hours	Pulse will be measured right before injection and after scanning.
Respiration frequency	3 hours	Respiration frequency will be measured right before injection and after scanning.
To assess disease severity in PSP	5 days	To assess disease severity in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan

Trial Locations

Locations (1)

Chang Gung Memorial Hospital,Linkou; 🇨🇳 Taoyuan City, Guishan Dist, Taiwan