with cognitive rehabilitation or exercise or both fared no differently than those who received sham( or placebo) treatments.“ We looked for interaction in a positive way between exercise and cognitive rehabilitation and, again, the result was not what we thought,” Professor Chataway explains.
However, study authors noted that the fact that processing speed can improve in people with progressive MS was something unknown before CogEx, emphasizing the importance of staying active across multiple domains when you have advanced disability.
“ What does this study say? You’ ve got to do something that has an effect on maintaining cognition in progressive MS,” says Professor Chataway.
We should be more aggressive in treating these comorbidities, says Professor Chataway, and he urges those who have had a heart attack or stroke— or who are at high risk for vascular disease— to continue taking statins if they were prescribed for those conditions.
COGEX STUDY ON COGNITIVE REHABILITATION AND AEROBIC EXERCISE
About 40 %– 80 % of people with MS have experienced some level of cognitive dysfunction, with higher rates among those with progressive forms of the disease. This includes impaired processing speed, learning and memory, executive function, and visual-spatial abilities. The most common of these is slower processing speed, which affects about half of all people with MS.
Earlier studies showed that both cognitive rehabilitation and exercise can improve cognitive difficulties associated with RRMS. However, studies involving people with progressive MS have been limited.
Dr. Anthony Feinstein from the University of Toronto, led CogEx 4, a randomized, multi-arm, sham-controlled trial that focused on progressive MS. For the study, 77 participants were assigned to cognitive rehabilitation plus exercise, 79 to cognitive rehabilitation plus sham exercise, 80 to exercise plus sham cognitive rehabilitation, and 75 to double sham interventions.
When it comes to improving processing speed in people with progressive MS, trial results did not support the researchers’ hypothesis that cognitive rehabilitation plus aerobic exercise were superior to either one alone. Processing speed improved in all groups, but those treated
Stimulation is very important, and the worst thing is not doing anything.”
- Professor Chataway.
Good trial design lays down a template and then other studies flow from that, he explains:“ Unless you do these big trials with good follow-up, theories just remain as theories. This lays down the template and tells us where to go next, what sort of modalities to try. It’ s exciting because it was not a drug trial, and, hopefully, there will be more trials like this to build on that.”
PHASE 3 HERCULES TRIAL ON TOLEBRUTINIB
The Phase 3 HERCULES trial 5, sponsored by the company Sanofi and led by Dr. Robert Fox, neurologist at Cleveland Clinic and NARCOMS Managing Director, evaluated the safety of tolebrutinib in people with non-relapsing SPMS. Over 1,100 trial participants were randomized to take either a daily oral dose of tolebrutinib or placebo for up to 48 months.
At the primary endpoint of six months, tolebrutinib was shown to have delayed onset of confirmed disability progression by 31 % compared to placebo. It was the first time a drug has been shown to delay disability progression in non-relapsing SPMS. In addition, tolebrutinib also significantly lowered the annualized rate of new / enlarging T2 lesions versus placebo.
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