A new Alzheimer’s drug has been unveiled, many are calling it a “revolutionary” new Alzheimer’s drug because it shows promise for slowing the rate of progression of the disease. This new immunotherapy drug is called aducanumab. It works by promoting the immune system response to interfere with the abnormal “plaque” formation in the brain. These plaques (called amyloid plaques) are thought to be associated with Alzheimer’s disease (AD). Amyloid plaques are thought to be the cause of the symptoms of the disease, but this theory has never been proven. Some experts believe that the plaques could be a byproduct of some other underlying cause.
But scientists warn consumers not to get too excited just yet, because the aducanumab study involved a limited number of participants; so the jury is still out when it comes to scientific evidence proving that the drug works.
The Study
The study, published in the peer-reviewed journal Nature, involved 165 people with early stage AD, who were given the new drug, aducanumab, to observe its effect on amyloid beta plaques. The study was conducted by researchers from the company that makes the new drug, in collaboration with Butler Hospital in the United States. The University of Zurich and Neurimmune in Switzerland (a biopharmaceutical company dedicated to the development of innovative immunotherapeutics for human diseases) was also involved in the study.
The study was aimed at gathering information about the effectiveness (removing plaques) as well as the safety of the drug. The study was not originally designed to evaluate the level of improvement in cognitive decline (although the researchers did look at that outcome). This phase-1b trial study, was a randomized controlled trial, designed to evaluate safety, effects, and side effects of the new drug on the brain. This type of study is usually done in the initial stages of drug research to determine whether the drug is safe and effective enough to continue doing further research. One group was given placebo injections, and the other group had 12 monthly injections of aducanumab(at various doses). At 24 and 52 weeks, PET scans of the brain were performed to evaluate the effect of the new drug.
The Study Outcome
The PET scans of the brain showed that at the end of the study, those who took the drug (and not the placebo) had cleared large areas of amyloid plaque. At the end of the study, the group that was given the highest dose of the aducanumab exhibited levels of amyloid that were almost within the normal range.
Cognitive testing indicated that everyone in the study (except those who took the highest dose) had a decline in mental functioning.
There were a few health risks resulting from side effects. In fac,t 20 participants stopped treatment due to adverse effects. Increase in swelling of the blood vessels of the brain was the most concerning side effect. Blood vessel swelling occurred in 41% of the study participants who took the highest dose.
In conclusion, the study did show that the drug reduces amyloid plaques in the brain, and that a reduction of this abnormal protein accumulation does improve mental functioning. However, the study did not show whether the drug could reverse symptoms of AD, once the disease process starts to progress. These outcomes “justify further development of aducanumab for the treatment of AD”, said study stresearchers.
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