Clinical Trials List
Protocol NumberAPN1607-NTUH
NCT Number(ClinicalTrials.gov Identfier)NCT04557865
2020-10-01 - 2023-12-31
Phase II
Not yet recruiting2
ICD-10 G21.9
Secondary parkinsonism, unspecified
Establishing 18F-PMPBB3 (APN-1607) PET imaging, genetic and plasma biomarkers for risk identification, disease progression and prognosis of tauopathy related Parkinsonism syndromes
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Trial Applicant
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Sponsor
National Taiwan University Hospital
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
Co-Principal Investigator
- TA-FU CHEN Division of Neurology
- RUOH-FANG YEN Division of Nuclear Medicine
- 李承軒 Division of Neurology
- Ming-Jang Chiu Division of Neurology
- CHIN-HSIEN LIN Division of Neurology
- 吳文超 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Parkinsonism syndromes
Objectives
We aim to develop an integrated approach combing 18F-PMPBB3 (APN-1607) PET scan and blood-based tau-specific biofluid biomarkers in a cohort of healthy controls and patients with tauopathy to develop reliable imaging and biofluid biomarkers for differentiating patients between tauopathy and synucleinopathy and variable parkinsonism-plus syndromes.
Test Drug
18F-PMPBB3 (APN-1607, MNI-958, or APN-0000455)
Active Ingredient
[[18F]1-Fluoro-3-((2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dien-1-yl)benzo[d]thiazol-6-yl
Dosage Form
IVT
Dosage
5
Endpoints
Primary Outcome Measures :
The distribution of tau measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan [ Time Frame: 1.5 years ]
Tau Distribution among patients with parkinsonism-plus syndromes, Parkinson's disease (PD), Alzheimer's disease (AD) spectrum, and normal controls measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan
Secondary Outcome Measures :
The amount of tau measured by SUVR as assessed by 18F-PM-PBB3 tau PET Scan as disease severity in patients with tauopathy parkinsonism-plus syndrome [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with clinical severity.
The amount of tau measured by SUVR as assessed by 18F-PM-PBB3 tau PET Scan as disease progression in patients with tauopathy parkinsonism-plus syndrome. [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with clinical progression speed.
To correlate the loading of tau deposition detected by 18F-PMPBB3 (APN-1607) correlate to plasma levels of total/phosphorylated tau. [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with plasma levels of total/phosphorylated tau.
To determine specific genetic susceptibility sub-groups are more vulnerable to tau deposition detected by 18F-PMPBB3 (APN-1607) in patients with tauopathy. [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with genetic variants of candidate genes.
Safety endpoints - ECG [ Time Frame: 1.5 years ]
Changes of electrocardiography (ECG) QT Interval before and after receiving 18F-PMPBB3 (APN-1607) scans.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1.5 years ]
Any discomfort after receiving 18F-PMPBB3 (APN-1607) scans.
Safety endpoints-Vital signs [ Time Frame: 1.5 years ]
Changes of blood pressure (changes of SBP >=20 mmHg) before and after receiving 18F-PMPBB3 (APN-1607) scans.
Safety endpoints-adverse event assessments [ Time Frame: 1.5 years ]
Any discomfort after receiving 18F-PMPBB3 (APN-1607) scans.
The distribution of tau measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan [ Time Frame: 1.5 years ]
Tau Distribution among patients with parkinsonism-plus syndromes, Parkinson's disease (PD), Alzheimer's disease (AD) spectrum, and normal controls measured by Standardized Uptake Value Ratio (SUVR) as Assessed by 18F-PM-PBB3 tau PET Scan
Secondary Outcome Measures :
The amount of tau measured by SUVR as assessed by 18F-PM-PBB3 tau PET Scan as disease severity in patients with tauopathy parkinsonism-plus syndrome [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with clinical severity.
The amount of tau measured by SUVR as assessed by 18F-PM-PBB3 tau PET Scan as disease progression in patients with tauopathy parkinsonism-plus syndrome. [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with clinical progression speed.
To correlate the loading of tau deposition detected by 18F-PMPBB3 (APN-1607) correlate to plasma levels of total/phosphorylated tau. [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with plasma levels of total/phosphorylated tau.
To determine specific genetic susceptibility sub-groups are more vulnerable to tau deposition detected by 18F-PMPBB3 (APN-1607) in patients with tauopathy. [ Time Frame: 1.5 years ]
The correlation between Tau distribution among patients with tauopathy parkinsonism-plus syndrome with genetic variants of candidate genes.
Safety endpoints - ECG [ Time Frame: 1.5 years ]
Changes of electrocardiography (ECG) QT Interval before and after receiving 18F-PMPBB3 (APN-1607) scans.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1.5 years ]
Any discomfort after receiving 18F-PMPBB3 (APN-1607) scans.
Safety endpoints-Vital signs [ Time Frame: 1.5 years ]
Changes of blood pressure (changes of SBP >=20 mmHg) before and after receiving 18F-PMPBB3 (APN-1607) scans.
Safety endpoints-adverse event assessments [ Time Frame: 1.5 years ]
Any discomfort after receiving 18F-PMPBB3 (APN-1607) scans.
Inclution Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Patients fulfill the criteria of United Kingdom Brain Bank Diagnostic Criteria of "possible" or "probably" PD.
Patients fulfill the criteria of MDS consensus criteria of "possible" or "probably" MSA.
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.
Patients fulfill the criteria of Work Group on Frontotempotal Dementia and Pick's Disease of "possible" or "probably" FTD.
Patients fulfill the Armstrong's criteria of "possible" or "probably" CBGD.
Patients fulfill the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroup for clinical diagnostic guidelines (NIA-AA-C) for MCI.
Patients fulfill the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroup for clinical diagnostic guidelines (NIA-AA-C) for AD.
Neurologically normal controls.
Age range 20-90 years
Written informed consent must be obtained before any assessment is performed.
Patients fulfill the criteria of United Kingdom Brain Bank Diagnostic Criteria of "possible" or "probably" PD.
Patients fulfill the criteria of MDS consensus criteria of "possible" or "probably" MSA.
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.
Patients fulfill the criteria of Work Group on Frontotempotal Dementia and Pick's Disease of "possible" or "probably" FTD.
Patients fulfill the Armstrong's criteria of "possible" or "probably" CBGD.
Patients fulfill the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroup for clinical diagnostic guidelines (NIA-AA-C) for MCI.
Patients fulfill the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroup for clinical diagnostic guidelines (NIA-AA-C) for AD.
Neurologically normal controls.
Age range 20-90 years
Exclusion Criteria
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
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
The Estimated Number of Participants
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Taiwan
150 participants
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Global
150 participants
