Role of Microglia in the Pathogenesis of Progressive Multiple Sclerosis

NCT03134716 | Active Not Recruiting

• 1 other identifier: T99/2016
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim is to evaluate whether translocator binding protein (TSPO)-imaging correlates to Expanded Disability Status Scale (EDSS) and other disease progression-related clinical and paraclinical parameters in a homogenous cohort of 40-50-year old MS-patients, who are at risk of progression. The A2A-AR expression in this cohort will also be studied using the adenosine A2A-receptor (A2A-AR)-binding radioligand 11C-TMSX. The study cohort will also form the basis for a later follow-up study, which will be performed to evaluate the prognostic value of baseline TSPO-imaging in terms of disease progression. TSPO-imaging could thus be used as an imaging biomarker to help identifying patients to therapeutically prevent progression of MS. At the 5 year time point synaptic density will be evaluated using 11C-UCB-J radioligand and PET imaging.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Correlation of microglial activation and MS progression

  11C-PK11195-radioligand binding using PET

  5 years

Secondary Outcomes (2)

• Correlation of 11C-TMSX radioligand binding and MS progression

  5 years

• Correlation of 11C-UCB-J-radioligand binding and cognition

  5 years

Study Arms (2)

Clinical follow-up

Clinical follow-up of MS-patients for 5 years. PET imaging data with PK11195 and TMSX only in baseline and with UCB-J at 5 years

Healthy controls

comparison of healthy controls' and MS patients' PET imaging data with PK11195 and TMSX only in baseline and with UCB-J at 5 years

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Relapsing remitting MS (RRMS) patients on the verge of secondary progression, age 40-50 years, MS-diagnosis for a minimum of five years before entering the study.

You may qualify if:

• RRMS, age 40-50 years, MS-diagnosis for a minimum of five years.

You may not qualify if:

• Previous or present treatment with immunosuppressive medication or biologicals. - Steroid treatment within 30 days of evaluation

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

Location

Related Publications (2)

• Laaksonen S, Sucksdorff M, Vuorimaa A, Kuhle J, Nylund M, Rajander J, Wahlroos S, Matilainen M, Saraste M, Airas L. Predictors of risk of secondary progression in multiple sclerosis. Ther Adv Neurol Disord. 2025 Sep 9;18:17562864251357276. doi: 10.1177/17562864251357276. eCollection 2025.

  PMID: 40951543 DERIVED

• Sjoros T, Saraste M, Matilainen M, Nylund M, Koivumaki M, Kuhle J, Leppert D, Airas L. Serum glial fibrillary acid protein associates with TSPO-expressing lesions in multiple sclerosis brain. Ther Adv Neurol Disord. 2025 Jul 28;18:17562864251352998. doi: 10.1177/17562864251352998. eCollection 2025.

  PMID: 40756531 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Correlation of blood biomarkers and MS progression

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura Airas, MD, Docent

  Turku University Hospital, division of clinical neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 1, 2017
• Study Start: April 1, 2016
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FI (1)