Nearly 7 million Americans aged 65 and older are living with Alzheimer’s dementia today. This number is predicted to increase to 13.8 million by 2060 unless there is some type of medical breakthrough that slows down the disease or outright cures it.
Alzheimer’s remains the fifth-leading cause of death among Americans aged 65 and older and companies are trying to change that with new drug trials in recent years. Some of the drugs that have been up for FDA approval have tried to slow down the cognitive decline that comes with Alzheimer’s.
One of the companies that trying to achieve this goal. They are one of the biggest pharmaceutical companies in the world.
In recent years they have produced an experimental Alzheimer’s medication. This drug is supposed to decrease the amyloid plaque level in people in the early stages of the disease. Amyloid plaque is developed in the brain around memory and creates cognitive issues if it spreads expeditiously.
This year this company indicated that the FDA accepted the company’s application with an accelerated priority review. There has been a study of this drug to get the drug to pass FDA regulations. The company conducted the study and was in the second phase trial.
The Study
The patients that were in the study showed early symptoms of the disease Alzheimer’s. The ages of participants in the study were 65 – 80. The patients were randomly assigned in a 1:1 ratio to receive donanemab. The patient would receive 700 mg for the first three doses and 1400 mg after that. Some would also receive a placebo during this 72-week process. This experiment resulted in a better composite score for cognition and for the ability to perform activities of daily living than the placebo at 76 weeks. Longer and larger trials are necessary to study the efficacy and safety of donanemab in Alzheimer’s disease (Mintun et al. 2021). One of the issues with the drug is that it has been shown that large doses of donanemab have caused brain swelling. Some of the patients would also experience feelings of nausea. This drug study is still in the beginning stages and is not ready for the market. But if the FDA approves this could be going in the direction of helping millions of people around the world.
Results
This could be a revolutionary drug that could change the medical landscape. Even if the effect is simply to slow progression, this could lengthen some quality years of life. Where the in the next generation a more effective drug could make the transition into Alzheimer if easier to handle.
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