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Effect of cladribine treatment on microglial activation in the CNS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519921-39-00
Enrollment
15
Registered
2024-12-19
Start date
2019-08-16
Completion date
Unknown
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

Change in microglial cell activation in different brain areas (NAWM normal appearing grey matter and the chronic active/ smoldering (slowly expanding) lesions) before and after 18 months of treatment with cladribine evaluated with [11C]PK11195-PET-imaging.

Detailed description

Change in microglial cell activation in different brain areas (normal appearing white matter (NAWM), normal appearing grey matter (NAGM) and the chronic active/ smoldering lesions) before and after 18 months of treatment with cladribine evaluated with QSM-MRI., Change in the total lesion load of the white matter MS plaques at different time points using MRI, Change in total brain, white matter (WM) and gray matter (GM) volumes using MRI at different time points of the study, Change in MD (mean diffusivity) and FA (fractional anisotropy) using DTI (diffusion tensor imaging at different time points of the study, Correlation of the baseline microglial activation status to the clinical outcome parameters at the end of the study (18 months) to evaluate whether high microglial activation is predictive of higher likelihood of progression and other measures of disability., Correlation of the baseline microglial activation status to the MRI parameters, Different microglial activation at baseline in the study group when compared to microglial activation in a group of age-matched previously imaged healthy controls, Different microglial activation in the study group to microglial activation in an independent group of previously imaged age-matched untreated MS-patients.

Interventions

Sponsors

Varsinais-Suomen hyvinvointialue
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in microglial cell activation in different brain areas (NAWM normal appearing grey matter and the chronic active/ smoldering (slowly expanding) lesions) before and after 18 months of treatment with cladribine evaluated with [11C]PK11195-PET-imaging.

Secondary

MeasureTime frame
Change in microglial cell activation in different brain areas (normal appearing white matter (NAWM), normal appearing grey matter (NAGM) and the chronic active/ smoldering lesions) before and after 18 months of treatment with cladribine evaluated with QSM-MRI., Change in the total lesion load of the white matter MS plaques at different time points using MRI, Change in total brain, white matter (WM) and gray matter (GM) volumes using MRI at different time points of the study, Change in MD (mean diffusivity) and FA (fractional anisotropy) using DTI (diffusion tensor imaging at different time points of the study, Correlation of the baseline microglial activation status to the clinical outcome parameters at the end of the study (18 months) to evaluate whether high microglial activation is predictive of higher likelihood of progression and other measures of disability., Correlation of the baseline microglial activation status to the MRI parameters, Different microglial activation at baselin

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026