Tomorrow heralds an exciting day in psychiatry. In The Netherlands, donanemab clinical trial results will be published for the first time. We anticipate that they will be positive as a similar drug trial was published last year, for the trial drug lecanemab, that slowed down the cognitive decline in early Alzheimer’s disease that now has approval from the US food and drug administration.

Lecanemab was approved in the USA in January 2023.

Lecanemab is not widely available in the UK now but a decision should be made later this year or next year. It is available to those who are in drug trials. The same goes for the rest of Europe.

To be available in the UK, lecanemab, would have to be approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Following Brexit, the MHRA will follow decisions made by the European Commission until January 2024.

Approval by the MHRA does not mean that a treatment will be available on the NHS. It would also need to be approved by the National Institute for Health and Care Excellence (NICE). For this decision, NICE will consider the benefits and risks as well as take into account how cost-effective the treatment is.

Before lecanemab is available, drug regulatory bodies will make a decision as to whether or not lecanemab is both effective and safe as a treatment for early Alzheimer’s disease. As well as it being cost-effective.

First do no harm is our oath and sometimes this appears to be impossible. However, trials that replicate previous trials and the results, can lead to confidence in new treatments and therefore licensed use in the UK. This is occurring now, as lecanemab is not without risk, no treatment is without risk.

The access to novel treatments is limited until the benefits to patients is clear and sometimes it becomes apparent in which type of the illness it is effective and less effective, or more risky following further trials. This is sensible but what if you are waiting for something that may improve your illness?

Large clinical trials usually take place in large clinical teaching establishments. These centres will have access to emergency treatments if needed, as well as exploratory and investigative equipment. These are usually attached to the universities with medical schools. This is where the academic excellence, research and funding is. These medical posts are highly sought after and competitive.

You will see, that if you do not live in an area with a medical school nearby, you will not be considered for a clinical trial, unless you are referred to the teaching hospital for assessment or treatment.

The wait for an effective treatment is long but its effectiveness has to be rigorously tested before it is widely available for doctors to prescribe. Thank you to all those people who have volunteered to be subjects in clinical trials to help researchers demonstrate the effectiveness and safety of novel treatments.