Living with dementia May 2009

By Nicki Collins and Anne Corbett

Finding out about clinical trials on new treatments for dementia and how to take part will now be easier thanks to a new initiative.

Alzheimer's Society and clinical research network DeNDRoN* are involved in an exciting new initiative that will allow people with dementia and their carers access to information about clinical trials on new treatments for dementia. The aim of the initiative is to make it easier for people to find out about ongoing trials, register themselves as participants in them, and communicate more effectively with the researchers involved.

There are currently 700,000 people in the UK living with dementia. Although there are some drugs available to slow the progression of symptoms, as yet there are no treatments to cure or prevent this devastating condition. Researchers continue to search for potential new drugs and there are some exciting candidates in the pipeline. However, all new drugs pass through a series of rigorous trials before being licensed for use in humans.

Stages of development
Following development in the laboratory, a drug is first tested for safety in animal models. Provided it performs well in these pre-clinical trials, trials in humans can begin. Clinical trials involve up to four separate studies, involving progressively larger numbers of participants. In the case of drugs designed to treat certain conditions, such as dementia, the final phases of trials will often involve people who have a diagnosis with the condition.

It is a lengthy and expensive process to put a drug through a clinical trial. From initial tests in humans, a trial can take ten years or more and cost more than £5 million. With more investment in research, more funding would be available for these studies, increasing the number of potential new treatments in the pipeline.

Getting involved
People with dementia and their carers frequently express great interest in being involved in testing new treatments, but it can be difficult for them to gain access to information about suitable trials. One carer says,

 'We were desperate to find a research trial to feel we were doing something. After considerable time and effort we thought we had struck it lucky. However, our hopes were short-lived as by the time we found the study my husband was no longer eligible'.

Clinical trials represent a valuable partnership between researchers and the public that underpins the development and licensing of new treatments. However, scientists often require participants to fulfil specific criteria in order to be involved in a trial, meaning that they struggle to find suitable volunteers. Alzheimer's Society recognises the need to raise awareness about this issue, and to recruit volunteers for trials in the UK.

Anyone who is interested in taking part in a clinical trial should first discuss the possibility with their GP or the health professional from whom they normally receive treatment. There are many clinicians across the UK who are recruiting for clinical trials from their offices or clinics. Alternatively, if they are not recruiting to clinical trials themselves, they may be able to suggest a trial that would be suitable.

Accessing information
Many NHS Trusts throughout England are supported by DeNDRoN (*Dementia and Neurodegenerative Diseases Research Network). Such research networks have been established by the National Institute for Health Research (NIHR) to ensure that both patients and healthcare professionals all over the country are able to access and benefit from participation in clinical research.

The NIHR holds a database of clinical trials and studies involving the NHS, all of which have met strict criteria in their design and coordination. This database is now available online through the link given below, and through Alzheimer's Society's website. People with dementia and their carers can access information about ongoing and upcoming clinical trials and register as potential participants.

Professor Clive Ballard, Director of Research at Alzheimer's Society, says,

'Turning scientific research into new treatments can only be achieved through clinical trials. We need to encourage these valuable partnerships between people with dementia, scientists and research funders, in order to improve the lives of people with dementia in the future.'

Dr Craig Ritchie, a consultant Old-Age Psychiatrist at Imperial College London, welcomes the new initiative. He says,

'There is immense optimism in the research community that with improved knowledge and a greater understanding of dementia through clinical research there will be a major breakthrough in pharmacological terms in halting disease progression in the not too distant future.'

A national solution to facilitate recruitment to clinical trials and enable patients' speedy access to appropriate research studies is also currently in development, with a dementia registry expected to be launched later this year. People will be invited to add their details to the registry by whoever is treating them, and can also refer themselves onto it.

Useful links
The portfolio of NIHR trials (including details of dementia studies) is available to the public via public.ukcrn.org.uk/search

You can also access the above via Alzheimer's Society website at alzheimers.org.uk/clinicaltrials Here, you will find more information about drug testing and details of clinical trials funded by the Society. This page also provides guidelines for using the clinical trials database.

For more information on the NIHR, go to www.nihr.ac.uk and for DeNDRoN see www.dendron.org.uk.

If you would like more information about the design and organisation of clinical trials go to www.ukcrc.org/publications/news/clinicaltrialsinformation.aspx

To request a clinical trials booklet, email info@ukcrn.org.uk