Some Good News in Alzheimer's Treatments
After the whole Graham scandal, people may be feeling a little hesitant about new drugs for Alzheimer’s Treatments.
However, recent news on another new treatment that would slow disease progression may be worth a look.
This study was a Phase Three placebo-controlled, double-blind randomized trial. It investigated the treatment potential of a monoclonal antibody that targets amyloid protein at an early stage.Alzheimer’s Treatments
The trial included 1795 people and gave an intravenous infusion of the drug or placebo biweekly for 18 months.
Cognitive decline was measured by the CDRsb, or clinical Dementia Rating Sum of Boxes, a numeric scale for quantifying symptom severity and dementia that assesses cognition and function.
According to a press release dated September 27, 2002, the new drug, called Lichenumab, reduced clinical decline by 27% from baseline when compared to placebo.
The difference was seen after 18, but not twelve months.
The drug also significantly reduced amyloid levels in the brain, which are thought by many to be intimately related to the disease.
That 27% reduction in cognitive decline translates to a zero-point, 45-point difference in scores between the placebo and drug groups.
This almost half-point difference was statistically significant, but we know that doesn’t automatically mean clinically significant or, put another way, that it translates to a meaningful difference for patients suffering from the disease.
It may be, but we’ll need more information to understand this better, especially since the drug has side effects that include brain swelling and bleeding.
We need to know if the benefits outweigh the risks. The makers of the drug were granted priority review by the FDA under the accelerated approval pathway after their Phase Two trial.
Results from the current Phase Three trial will be used to seek full approval. Application data for drug approval have also been submitted to Japan’s Pharmaceuticals and Medical Devices Agency.
It looks like the full results will be presented sooner at the scientific meeting, and hopefully, we’ll see a full paper shortly.
Until then, It will be difficult to make a full judgment of the outcomes of the trial. Some experts seem cautiously optimistic, others not as much.
Even if the treatment makes a reasonable difference in patient outcomes, giving them more and better time, research will need to continue so we can develop other treatments and maybe, hopefully someday, a cure.
The role of amyloid protein and Alzheimer’s Treatments isn’t as set or as central as it is sometimes presented.
As quoted in a Nature article in the study, amyloid is associated with the problem, but it isn’t the problem.
We’ve got other components, like the Tau protein, that also appear to play a major role in disease progression.
It’s possible that a cocktail of drugs would provide the best treatment outcomes. In any case, though, we’re ready to celebrate if the treatment proves to be meaningful for patients and their families, and we look forward to finding that out.
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We’d especially like to thank our research associates, James Glasgow, Joe Civics, Edward Lilahome, and Brian Nam.