Alzheimer’s disease is one of the most common causes of dementia worldwide and the population of individuals with the disease is projected to double by 2050. Alzheimer’s disease is a fatal disorder that causes the degradation of neural networks and brain tissue volume. Common symptoms include memory loss, misplacing items, changes in sleep patterns and forgetting names and places. Until recently, there was no FDA approved treatment to cure Alzheimer’s disease.
In 2021, a new drug was approved by the FDA called Aducanamab that targets the protein clusters causing the disease (Aβ aggregates). The drug is primarily used for individuals who are in the mild to moderate stages of the disease. It seems great, and if what is claimed actually worked, the drug will slow or stop the progression of the disease. However, the drug’s debut to the market has caused much controversy in the field of medicine due to some aspects of the clinical trials.
The first concern many have is the inclusion criteria for the study. While all participants were tested positive for amyloid plaques (protein clusters causing the disease) and have early symptoms of the disease, the Mini Mental State Examination (MMSE) score which measures cognition appeared to be skewed to some people. A score of 25-30 is considered normal cognition, 21-24 is considered mild cognitive impairment, 10-20 is categorized as moderate dementia, and a score of nine or under is categorized as severe dementia. In order for individuals to be eligible for the study, their MMSE score had to be 24-30, which would mean the majority of participants are categorized as having normal cognition or borderline mild dementia.
Another major concern is some of the fatal side effects experienced by some participants. One of these side effects is amyloid related brain hemorrhages (bleeding of the brain), which 12.3% of low dose participants and 19.1% of high dose participants experienced. Another fatal side effect of the drug is amyloid related oedema (excess fluid in bodily tissues) which 20.5% of low dose participants and 35% of high dose participants experienced.
The last major concern is that there were only two Aducanamab trials, one of which was positive and the other negative. Many believe that this would make the data insufficient especially with the consideration that the negative trial was terminated.
The data showed promising signs of a decreased rate of cognitive decline but with multiple concerns including trial eligibility, side effects, low number of trials and conflicting data. The trial only went through the second phase and many believe the drug should go through the third phase before it becomes FDA approved and commercially available. There are many opinions on the release of the drug, with both support and opposition. To make an educated opinion, more research must be done as well as hearing from both perspectives on the drug’s release.
