Clinical trial NCT04541836: Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy
Official title: Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Progressive Supranuclear Palsy
Keywords: tauopathy
Progressive Supranuclear Palsy
F-18 APN1607 PET
F-18 PMPBB3 PET
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects
timeFrame: 5 days
Secondary outcomes:
measure: To assess disease severity in PSP
timeFrame: 5 days
measure: To assess disease progression in PSP
timeFrame: 1.5 year
measure: Blood pressure
timeFrame: 3 hours
measure: Pulse
timeFrame: 3 hours
measure: Respiration frequency
timeFrame: 3 hours
measure: Adverse events collection
timeFrame: 5 days
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital,Linkou
state: Guishan Dist
Study officials:
References: