A high daily dose of simvastatin improves multiple sclerosis patients’ cognitive function, according to a new analysis of Phase 2 clinical trial results.
The British team that did the research will start a study soon on whether simvastatin, which goes by the brand name Zocor and other labels, can also slow the progression of MS disability.
The researchers’ latest analysis was published in the journal Lancet Neurology. The title was “Effect of high-dose simvastatin on cognitive, neuropsychiatric, and health-related quality-of-life measures in secondary progressive multiple sclerosis: secondary analyses from the MS-STAT randomised, placebo-controlled trial,”
About 100,000 people in the United Kingdom have MS. As the disease progresses, at least half of patients develop secondary progressive MS (SPMS), characterized by greater disability and gradual worsening of their condition.
Cognitive impairment, which can start early in MS, affects more than 80 percent of SPMS patients. The areas most frequently impaired are attention, memory, the speed at which a person processes information, and what scientists call executive function skills, which help people get things done. Those with impaired executive function skills have difficulty engaging in day-to-day activities and have decreased quality of life.
Jeremy Chataway and colleagues at University College London Hospitals reported in 2014 that a high daily dose of simvastatin, a cholesterol-blocking drug, could slow SPMS patients’ brain atrophy, or shrinkage.
The team confirmed the results in their new analysis of the Phase 2 MS-STAT trial (NCT00647348) results.
Researchers had randomly assigned 133 SPMS patients in the 24-month, double-blind, controlled trial to either an 80-mg dose of simvastatin a day or a placebo. The team used a battery of tests to determine changes in patients’ cognitive function 12 and 24 months after treatment.
Patients who took simvastatin had higher frontal-lobe-function improvement scores than patients on the placebo. The simvastatin group also had more improvement in physical function than the placebo group.
“The study is clinically important because patients with MS, in particular those with progressive MS, have a significant but under-reported cognitive burden, such as memory, processing and mental flexibility,” Chataway said in a news release. “We have shown in this early work that simvastatin can help that part of it.
“This is an important small step in reinforcing the need to study cognition in MS and to continue to advance its treatment,” he said. “Following on from this study we would recommend focusing the study on those aspects of cognition which are most frequently affected.”
The Biomedical Research Centre at University College London Hospitals is supporting Chataway’s work.
And the team just received a £6 million — or $6.74 million — grant to conduct a Phase 3 clinical trial on whether high-dose simvastatin can slow the rate of disability progression in MS over three years.
“It is encouraging to see the broader positive impact of simvastatin, particularly on cognitive function and quality of life — two key areas in MS — and particularly challenging in those with progressive disease,” said Dr. Alan Thompson, dean of the Faculty of Brain Sciences at University College London. “These results further underline the importance of the Phase 3 trial.”
The trial will enroll 1,180 people with SPMS at almost 30 centers in the United Kingdom. The first participants are expected to receive the drug later this year.