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NCT04242056
To Study the Pathophysiological Features of Multiple Sclerosis
Phase 1, PHASE2 trial testing 18F-PM-PBB3 in Multiple Sclerosis in 38 participants. Status unknown.
30 September 2020
Quick facts
| Lead sponsor | Chang Gung Memorial Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 38 |
| Start date | 20 February 2020 |
| Primary completion | 30 September 2020 |
| Estimated completion | 30 September 2020 |
Drugs / interventions tested
- 18F-PM-PBB3 — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Neurofilament Light Chain — all drugs for Neurofilament Light Chain →
- Glial Fibrillary Acidic Protein — all drugs for Glial Fibrillary Acidic Protein →
Sponsor
Chang Gung Memorial Hospital
Who can join
Adults 20 to 70, any sex, with Multiple Sclerosis or Neurofilament Light Chain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04242056
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04242056 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chang Gung Memorial Hospital
- Last refreshed: 27 January 2020
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