Clinical Trial

Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

Study acronym: PRO-COG
Completed
View on ClinicalTrials.gov →
Summary
Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients. Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.
Protocol Amendment History 3 changes
critical Trial completed 2026-08-05
notable Primary completion pushed: 2026-03 -> 2026-04-15 2026-08-05
minor Completion pushed: 2026-03 -> 2026-04-15 2026-08-05
Trial Details
NCT Number NCT03455582
Lead Sponsor University Hospital, Bordeaux
Collaborators: Roche Pharma AG
Conditions Multiple Sclerosis, Primary Progressive
Enrollment 66 participants
Start Date 2018-09-24
Primary Completion 2026-04-15 (estimated)
Study Completion 2026-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-04