Clinical Trials List
Protocol Number201802146A0
NCT Number(ClinicalTrials.gov Identfier)NCT04242056
2019-08-01 - 2022-10-31
Phase II
Recruiting1
To study the pathophysiological features of multiple sclerosis: combined multi-modalities of amyloid and tau images associated with serum neurofilament light chain levels
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Trial Applicant
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Sponsor
Chang Gung Memorial Hospital
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Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
Linkou Chang Gung Medical Foundation
Chairman/Global PI
徐榮隆
Co-Principal Investigator
- 蕭穎聰 Division of Radiology
- 杜振豐 Division of Radiology
- Long-Sun Ro Division of Neurology
- Kun-Ju Lin Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
*PRESENILE DEMENTIA;SENILE DEMENTIA, UNCOMPLICATED;DEMENTIA IN CONDITIONS CLASSIFIED ELSEWHERE;AMNESTIC SYNDROME
Objectives
Multiple sclerosis (MS) is the most common chronic inflammatory disease of the central nervous system1, whose demyelination is the pathological hallmark. MS is characterized by neuroinflammation, demyelination, axonal damage, and neurodegeneration2. The demyelination state in brain and the clinical course are difficult to predict in the early stage of disease. Recently, several neuroimaging and fluid biomarkers had been explored in MS. Using brain amyloid positron emission tomography (PET) in active MS had showed that both the damage sites and normal appearance white matter had a lower intensity than non-active MS. The result suggests a predictive role that the intensity from amyloid PET could reflect the disease activity and link to early myelin damage. The levels of tau protein in cerebrospinal fluid (CSF) had also been showed a negative correlation with brain atrophy, which is a prognostic marker for MS. In fluid biomarkers, both neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) had been used in MS and reported correlations with disease severity, the extent of neuroinflammation and progression. In current study, investigator will enroll 38 participants with MS and evaluate their clinical severity; measure the WM lesion and disease activity by magnetic resonance imaging (MRI); myelination state and amyloid deposition by amyloid PET scan; tau deposition by state of-art tau PET scan. Investigator also measure the serum levels of NfL and GFAP as the index of axonal injury and disease activity. The relationship between disease severity, brain myelination, tau deposition and serum levels of NfL will be discuss.
Test Drug
(1)[F18] AV-45 (2) [F-18] PM-PBB3
Active Ingredient
(E)-4-(2-(6-(2-(2-(2-[18F] fluoroethoxyl) ethoxy)ethoxy)pyridine-3-yl)vinyl)-N-methylbenzenamine
[18F]1-Fluoro-3-((2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dien-1- yl)benzo[d]thiazol-6-y、
[18F]1-Fluoro-3-((2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dien-1- yl)benzo[d]thiazol-6-y、
Dosage Form
injection
injection
injection
Dosage
10
10
10
Endpoints
Primary Outcome Measures :
Correlation between hyperintensity lesions in FLAIR MRI and demyelination in amyloid PET image [ Time Frame: 3 years ]
Investigator would be able to find the topographical correlation between hyperintensity lesions in FLAIR MRI and hypointensity lesions in amyloid PET, measurement by overlapping volume (ml) and overlapping ratio (%)
Secondary Outcome Measures :
Correlation between clinical parameters (EDSS) and hyperintensity lesions in FLAIR MRI and hyperintensity region of tau PET image light chain and GFAP levels. [ Time Frame: 3 years ]
Investigator would be able to find the EDSS correlation between whole brain hyperintensity lesions in FLAIR MRI (ml) and hyperintensity regions of tau PETwe will take this advantage to perform the study and explore the relationship between serum neruofilament light chain and GFAP levels.
Correlation between clinical parameters (EDSS) and serum NfL levels [ Time Frame: 3 years ]
Investigator would be able to find the EDSS correlation between EDSS and serum NfL levels
Correlation between hyperintensity lesions in FLAIR MRI and demyelination in amyloid PET image [ Time Frame: 3 years ]
Investigator would be able to find the topographical correlation between hyperintensity lesions in FLAIR MRI and hypointensity lesions in amyloid PET, measurement by overlapping volume (ml) and overlapping ratio (%)
Secondary Outcome Measures :
Correlation between clinical parameters (EDSS) and hyperintensity lesions in FLAIR MRI and hyperintensity region of tau PET image light chain and GFAP levels. [ Time Frame: 3 years ]
Investigator would be able to find the EDSS correlation between whole brain hyperintensity lesions in FLAIR MRI (ml) and hyperintensity regions of tau PETwe will take this advantage to perform the study and explore the relationship between serum neruofilament light chain and GFAP levels.
Correlation between clinical parameters (EDSS) and serum NfL levels [ Time Frame: 3 years ]
Investigator would be able to find the EDSS correlation between EDSS and serum NfL levels
Inclution Criteria
Inclusion Criteria:
Age between 20-75 years old
Multiple Sclerosis patients
Age between 20-75 years old
Multiple Sclerosis patients
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 severe 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.
Patients in whom MRI was contraindicated or patient had claustrophobia.
History of severe allergic or anaphylactic reactions particularly to the tested drugs.
History of positive test for human immunodeficiency virus (HIV).
Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≧ 3X the upper limit of normal values).
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 severe 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.
Patients in whom MRI was contraindicated or patient had claustrophobia.
History of severe allergic or anaphylactic reactions particularly to the tested drugs.
History of positive test for human immunodeficiency virus (HIV).
Indication of impaired liver function as shown by an abnormal liver function profile at screening (eg. repeated values of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] ≧ 3X the upper limit of normal values).
The Estimated Number of Participants
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Taiwan
38 participants
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Global
38 participants
