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

Progressive Supranuclear Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541836
• Other study ID #: 201901999A0
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2020
• Source: Chang Gung Memorial Hospital
• Contact: Kun-Ju Lin, MD PhD
• Phone: 886-3-3281200
• Email: kunjulin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

Diagnostic Test:
• 18F-PMPBB3
single intravenous injection 5mCi 18F-PMPBB3 per scan

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital,Linkou	Taoyuan City	Guishan Dist

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood pressure	Systolic and diastolic pressure of subjects will be measured right before injection and after scanning.	3 hours
Secondary	Pulse	Pulse will be measured right before injection and after scanning.	3 hours
Secondary	Respiration frequency	Respiration frequency will be measured right before injection and after scanning.	3 hours
Secondary	Adverse events collection	Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.	5 days