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

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Chang Gung Medical Foundation

Status

Enrolling

Conditions

Progressive Supranuclear Palsy

Treatments

Diagnostic Test: 18F-PMPBB3

Study type

Observational

Funder types

Other

Identifiers

NCT04541836
201901999A0

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

healthy control
Description:
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.
Treatment:
Diagnostic Test: 18F-PMPBB3
PSP
Description:
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.
Treatment:
Diagnostic Test: 18F-PMPBB3

Trial contacts and locations

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Central trial contact

Kun-Ju Lin, MD PhD

Data sourced from clinicaltrials.gov

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