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

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.

Study Overview

• Status: Recruiting
• Conditions: Progressive Supranuclear Palsy
• Intervention / Treatment: Diagnostic test: 18F-PMPBB3

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 Type: Observational
• Enrollment (Anticipated): 28

Contacts and Locations

• Study Contact: Name: Kun-Ju Lin, MD PhD; Phone Number: 2625 886-3-3281200; Email: kunjulin@gmail.com

Study Locations

• Taiwan
  • Guishan Dist
    • Taoyuan City, Guishan Dist, Taiwan, 333
      • Recruiting
      • Chang Gung Memorial Hospital,Linkou
      • Contact: Kun-Ju Lin; Phone Number: 2632 03-3281200; Email: kunjulin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PSP patient will be enrolled from primary care clinic or hospital, control (healthy subjects) will be enrolled from community.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 18F-PMPBB3; single intravenous injection 5mCi 18F-PMPBB3 per scan; Other Names: 18F-APN-1607; 18F-MNI-958; 18F-APN-0000455
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.	Diagnostic test: 18F-PMPBB3; single intravenous injection 5mCi 18F-PMPBB3 per scan; Other Names: 18F-APN-1607; 18F-MNI-958; 18F-APN-0000455

What is the study measuring?

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
Adverse events collection	Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.	5 days
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Progressive Supranuclear Palsy; tauopathy; F-18 APN1607 PET; F-18 PMPBB3 PET
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Tauopathies; Cranial Nerve Diseases; Ocular Motility Disorders; Ophthalmoplegia; Paralysis; Supranuclear Palsy, Progressive
• Other Study ID Numbers: 201901999A0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No