Can biomarkers make clinical trials for Alzheimer’s disease cheaper and faster?

Lead Investigator: Dr David Cash

Institution: University College London

Grant Type: Dementia Research Leader Fellowship

Start date: February 2025

Duration: 48 months

Amount: £549,959.89

Project summary

With effective treatments for Alzheimer’s disease now available, it is critical to test whether these drugs can also delay the onset of symptoms for people at preclinical stages of the disease, before symptoms have appeared.

Dr Cash will study which disease biomarkers can be used to successfully identify people with Alzheimer’s disease before their symptoms appear. By doing so, people can be offered the opportunity to take part in clinical trials sooner. This will speed up the development of treatments, getting them to the market faster, and lowering the cost of clinical trials.

Ultimately, this research will bring us one step closer to effective treatments for Alzheimer’s disease, which are desperately needed by people living with the disease.

Project background

All treatments need to be tested in clinical trials to make sure that they are safe and effective. However, trials can take a long time to complete and need thousands of people to participate and as a result are very expensive It also means that people must wait a long time for drugs to be approved and available.

There are many new treatments for Alzheimer’s disease currently in clinical trials. So far, these new treatments are only being tested in people who already have symptoms of the disease. However, changes in the brain, such as plaques and tangles which ultimately damage and kill nerve cells, can form years before any symptoms begin. Researchers believe we might be able to treat the disease earlier, during the ‘silent’ period which is called the preclinical stage of Alzheimer’s disease.

If treatments were developed to remove harmful plaques and tangles at earlier stages of the disease, this could prevent future damage. However, to run clinical trials for early treatments, we must first find people at the preclinical stages of Alzheimer’s disease. This can be done by using biomarkers, which detect unique changes in people’s bodies which are associated with diseases, such as dementia.

By running more efficient clinical trials, we could develop treatments that target dementia earlier, preventing damage and ensuring people living with dementia would have a higher quality of life, as would their loved ones.

What does this project involve?

Dr Cash will study how detecting biomarkers, the early warning signs in the body for a disease, can shorten the time and lower the cost of trials in people with Alzheimer’s disease before symptoms have appeared.

Firstly, Dr Cash will establish at which point during the disease these biomarkers change and what this tells us about the risk of developing dementia in the future. If there is a strong link between biomarkers and future risk of dementia, then the biomarkers should be a useful measure to use in a clinical trial.

This research will examine biomarker changes from large amounts of data available from previous research studies. This data was collected from people who have no symptoms of Alzheimer’s disease, however around 20% of these people are in the preclinical stages. Using this data, Dr Cash will determine how likely it is that people will develop symptoms. He will also work with experts to use these results to design future clinical trials.

How will this project help people with dementia?

Through this work, Dr Cash hopes to determine how we can use biomarkers to design better clinical trials which will allow people to access essential treatments before symptoms develop, limiting damage caused by dementia.

Dr Cash aims to share his findings with researchers, drug companies, and people who are involved with designing clinical trials. By helping to speed up clinical trials and make them cheaper, Dr Cash hopes to identify effective drugs sooner, and get them to market quicker, helping people living with Alzheimer’s disease access essential treatments.