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Trial record 1 of 1 for:    NCT04541836
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Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy

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ClinicalTrials.gov Identifier: NCT04541836
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Progressive Supranuclear Palsy 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 Design
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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Tau Distribution Among Progressive Supranuclear Palsy (PSP), and Normal Subjects [ Time Frame: 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 :
  1. To assess disease severity in PSP [ Time Frame: 5 days ]
    To assess disease severity in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan

  2. To assess disease progression in PSP [ Time Frame: 1.5 year ]
    To assess disease progression in PSP subjects by SUVR as Assessed by 18F-PM-PBB3 tau PET Scan

  3. Blood pressure [ Time Frame: 3 hours ]
    Systolic and diastolic pressure of subjects will be measured right before injection and after scanning.

  4. Pulse [ Time Frame: 3 hours ]
    Pulse will be measured right before injection and after scanning.

  5. Respiration frequency [ Time Frame: 3 hours ]
    Respiration frequency will be measured right before injection and after scanning.

  6. Adverse events collection [ Time Frame: 5 days ]
    Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04541836


Contacts
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Contact: Kun-Ju Lin, MD PhD 886-3-3281200 ext 2625 kunjulin@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital,Linkou Recruiting
Taoyuan City, Guishan Dist, Taiwan, 333
Contact: Kun-Ju Lin    03-3281200 ext 2632    kunjulin@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04541836    
Other Study ID Numbers: 201901999A0
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
tauopathy
Progressive Supranuclear Palsy
F-18 APN1607 PET
F-18 PMPBB3 PET
Additional relevant MeSH terms:
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Paralysis
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases