On 7^th June 2021, the Food and Drug Administration (FDA) approved a new treatment for Alzheimer’s patients in the US. This is the first treatment to be approved in almost two decades, and the first to target the cause of Alzheimer’s disease rather than just the related symptoms. However, gaps in clinical trial data have left developers, Biogen, requiring further trials. What is new about this treatment and what do the data show so far?

Alzheimer’s disease is the most common type of dementia, encompassing brain disorders which often lead to a progressive loss of brain f unction with symptoms such as memory loss and confusion. Alzheimer’s affects between 50-75% of those diagnosed with dementia and it is a terminal condition. The number of patients suffering with dementia in the UK, is projected to rise from the current figure of 850,000 to 1.6 million by 2040, with those over 80 at highest risk of developing the disease. Despite decades of research, new approved treatments for Alzheimer’s disease have stagnated. Until now, medicated treatments had targeted the symptoms of the disease, rather than the root cause, temporarily easing symptoms such as memory loss, or slowing disease progression in patients in mild to moderate stages of the disease.

“Delaying the onset of dementia by five years would halve the number of deaths, saving 30,000 lives a year.”

Alzheimer’s Society, UK

Even the cause of Alzheimer’s disease is contentious however, with numerous theories under investigation. The leading hypothesis, which led to the recently approved Biogen treatment, targets the build-up of a protein (called amyloid) in the brain which is considered an indicator (or biomarker) of the disease. It had been observed that Alzheimer’s patients, with no other conditions, were producing an immune response and generating antibodies against the amyloid protein which clumped around neurons, forming plaques, and eventually leading to neuron degeneration. Biogen focused on creating Aducanumab (brand name Aduhelm), an antibody which specifically binds to these amyloid plaques in the brain. Researchers collected Alzheimer’s patients’ memory B cells and selected those capable of producing antibodies which were highly selective towards amyloid. Their aim was to interrupt and remove the plaques, hopefully preserving neuronal function. After Adhuhelm’s approval, the FDA’s director of the Center for Drug Evaluation and Research, Dr Cavazzoni reported the “FDA has determined that there is substantial evidence that Aduhelm reduces amyloid plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients”.

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