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New Alzheimer’s medication approved by FDA

The US Food and Drug Administration (FDA) has approved a new drug for the treatment of Alzheimer’s disease — the first of its kind for twenty years. What does this mean for those affected by Alzheimer’s disease in India?

brain disease dementia Copyright: vampy1 / 123RF Stock PhotoAducanumab, from the company Biogen, is a monoclonal antibody that aims to slow the gradual progression of symptoms such as memory loss and cognitive decline. These symptoms are hallmark characteristics of Alzheimer’s disease, with the symptoms gradually worsening until an individual is left with severe memory loss, and often cognitive decline to the point that their capacity to function without round-the-clock care is limited.

Aducanumab acts upon one of the molecules thought to be responsible for the development of Alzheimer’s disease — the amyloid protein. The medication has been designed focusing on the amyloid hypothesis of Alzheimer’s disease. In short, this considers that amyloid protein is the primary cause of disease. Amyloid protein is potentially involved in communication between synapses — an electrical/chemical junction between neurons. The amyloid protein, the hypothesis says, can be broken down into smaller molecules that can bind to themselves, forming plaques that can cause damage to the brain.

Amyloid plaques have been found in autopsies of patients known to have severe Alzheimer’s disease, and there are a number of genes implicated in increasing amyloid burden –– these include mutations to the APP gene, Presenilin-1 as well as APOE-ε4. All of these have been inserted into transgenic mouse models to study the disease, producing excess amyloid plaques and Alzheimer’s symptoms. This evidence supports the amyloid hypothesis.

Issues occur when attempting to translate the data produced during clinical trials conducted on mice to human trials. The genes inserted into the mice represent familial Alzheimer’s disease, in which the disease can be attributed to a passed-down genetic mutation in a gene often related to amyloid protein. Familial Alzheimer’s however, only represents around two to three percent of all Alzheimer’s cases in humans.

These issues have translated into the trials for Aducanumab. Two trials were stopped in March 2019 because the medication did not show any notable alleviation of symptoms compared to a placebo control group. Biogen later announced that a reanalysis of data from a longer term trial showed that a high dose reduced and slowed the onset of Alzheimer’s symptoms.

The initial lack of supporting evidence, followed by the sudden announcement that the medication does in fact work, has left the scientific community dubious about the medication. 

“The development of this drug has been going on for several years with several trials having been conducted and a marginal benefit has been shown in terms of reducing the amyloid load in the early stages of the disease. It is to be noted that these trials were conducted on patients who were in the early stages of the disease,” a researcher from the Centre for Brain Research, Indian Institute of Science, Bengaluru told The Indian Express.

Worth noting is that the FDA has only approved the medication in the US under very specific circumstances. Those eligible must be in the early stages of Alzheimer’s disease, and have undergone a PET scan in order to establish that the root cause of the condition can be traced back to amyloid plaques. 

Due to this, the actual impact the drug may have is up for debate. In this fact lies the controversy surrounding the drug. The evidence to support its use is limited, and scientific bodies are far more cautious regarding its use and approval. However, charities, organisations and the patients themselves are desperate for any measure of hope, and so are far more likely to seek the approval of the drug, regardless of its patchy track record.

According to the Alzheimer’s Association, “in India, more than four million people have some form of dementia.” By 2030, the number is projected to rise to 7.6 million. Dr Amit Dias, one of the authors of a Lancet study entitled “forty percent of dementia cases could be prevented or delayed by targeting 12 risk factors throughout life” previously provided Health Issues India with an expert opinion on the situation regarding dementia and Alzheimer’s disease in India 

“We are talking about large numbers….it is estimated that worldwide fifty million people live with dementia, and the number is projected to increase to 152 million by 2050, rising particularly in the low- and middle- income countries where around two thirds of people with dementia live. Dementia affects individuals, their families and the economy, with global costs estimated to about US$1 trillion. The first step in this direction is to recognise that it is a problem and understand that it’s a public health priority.

“India is a large country, so though we have a comparatively younger population, in terms of total numbers we are estimated to have around four million people with dementia in the country. Moreover, it’s a myth to say that we are equipped to deal with the situation. We had done a study on the care arrangements for people with dementia and it revealed that due to stigma and lack of awareness more than ninety percent of the people with dementia in India do not even get a diagnosis and deal with the condition without a clue, and this adversely affects the life of the person with dementia as well as the caregivers”

This new medication, while encouraging to a degree, is not a cure, rather, a means to delay the onset of the symptoms of Alzheimer’s disease. It is a harsh reality that many forms of dementia are increasing in prevalence across the globe, none of which can currently be cured, or, in many cases, even treated effectively. As such, there needs to be a workable plan in place in order to deal with this reality. 

Dr Amit Dias made the following suggestions to develop effective government policies in order to cope with India’s ever growing burden of Alzheimer’s disease and dementia

  • Start with making dementia a public health priority in the country
  • Inform the states to develop services for people with dementia
  • Raise awareness and help fight stigma associated with dementia
  • Train caregivers to provide home care
  • Focus on building capacity of primary care
  • Develop special clinics such as memory clinics for people with dementia to get a diagnosis and also post-diagnostic support
  • Work on the concept of developing dementia friendly communities
  • Above all focus on prevention of dementia. The recent Lancet report clearly indicates that forty percent of the case of dementia can be prevented or delayed by focusing on the twelve risk factors. 

Given the lack of a cure, or even a reliable means to delay the onset of Alzheimer’s disease, public policy is crucial in aiding both those with the disease themselves, as well as their families who, in many cases, become full time carers. This has left many in India struggling with poverty as they are forced out of work to care for elderly relatives. Given the rapidly increasing cases among an aging population, the lack of a public health policy could see both the economy and the healthcare system overwhelmed in the coming years.

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