Interim results from a safety study of aducanumab in people with very early stage Alzheimer’s, show the drug reduces the amount of the amyloid plaques in the brain, with an increasing effect as the dose increases.
Advertisement
Using the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog), results demonstrated that women’s rate of decline (2.3 points/year) was twice as fast as that of men’s decline (1.05 points/year). The idea was that by the end of the study, the participants who had been taking the drug all along should show greater improvements in cognitive skills than those who switched midway through. It is due to complete in October 2016.
According to Dean Hartley of the Alzheimer’s Association, the brand new factor concerning the drug and their workforce is that they’re “altering the course of the disease“.
Roche also had updated results from a previously-reported trial of its gantenerumab candidate that failed to show a benefit on cognition.
The three companies – Eli Lilly, Roche and Biogen – have all been developing drugs based on genetically engineered monoclonal antibodies to mimic the actions of the immune system and target the buildup in the brain of beta amyloid, an abnormal form of protein that builds up as plaque and can destroy brain cells.
When researchers compared the cognitive function of the two groups two years into the study, the difference was “statistically significant”, Eli Lilly said in a statement.
However, there was a non-significant slowing of cognitive decline that seemed to be dose-dependent, according to Biogen, once again giving a pointer that amyloid therapy might have some impact if delivered early enough. The trial still has another two years to run.
“After a decade of no new therapies for dementia, today’s news is an exciting step forward”, said Dr Doug Brown, the organisation’s R&D director.
“We are particularly excited about these data because this is the first time the delayed-start methodology has been implemented for an Alzheimer’s disease clinical trial”, said Hong Liu-Seifert, a study research advisor at Eli Lilly.
Advertisement
“If they are positive, these drugs will be the first identified to directly interfere with the disease process and slow the progression of Alzheimer’s”.
