Controlled studies comparing therapies with respect to their effects on rate of cognitive decline in multiple sclerosis (MS) are lacking. In addition, current open-label studies or clinical trials on cognitive functioning have not selected patients on criteria for cognitive dysfunction. So, the question remains if a cognitive-based early initiation of highly effective treatment should be considered.
Researchers from Spain initiated the CogEval project, comparing high efficacy versus usual first-line treatment in patients with cognitive dysfunction, evaluated via Processing Speed Test (PST) . The PST is a self-administered iPad®-based tool to measure MS-related deficits in processing speed and its use has shown an advantage over pen-and-paper cognitive batteries because of its ease of administration and a standardised scoring system.
The aim of CogEval is to determine whether early initiation of highly effective disease-modifying therapy (DMT) in patients with relapsing-remitting MS is associated with a decreased rate of longitudinal cognitive decline. Dr Andrés Labiano-Fontcuberta (University Hospital “12 de Octubre”, Spain) presented the methods and objectives of this randomised open-label pilot study. Patients who are not under consideration for initiation of high-efficacy DMT but whose results on PST are below normal limits will be enrolled. Participants will randomly be allocated into 2 groups:
- experimental or intervention group, initiating highly-effective DMT (natalizumab, ocrelizumab, or alemtuzumab); and
- control group without intervention, which will continue with the conventional first-line treatment.
After a treatment period of 24 weeks, change from baseline PST and proportion of cognitive decline-free patients will be assessed. Recruitment is still ongoing.
- Labiano-Fontcuberta A. CogEval project: tackling unmet multiple sclerosis-related cognitive challenges. ECF 28th Annual Meeting. Abstract 41.
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