The Well-being and Health for People with Dementia (WHELD) study was a randomised controlled trial in 16 care homes examining non-pharmacological interventions for people with dementia. The interventions tested were a person-centred care training programme for care home staff, used alone or in combination with a social interaction package, an exercise programme or a structured antipsychotic review process. These interventions were based on person-centred care, personhood in dementia, personalized care planning and problem-solving theory. The aim was to develop and test a realistic approach to care for use in care homes, which improves key symptoms and quality of life of residents.
The trial demonstrated that the combination of person-centred care training, social intervention and antipsychotic review can reduce antipsychotic use and improve quality of life without worsening neuropsychiatric symptoms such as agitation and aggression. These interventions also resulted in a 30% reduction in mortality, which is statistically significant. These findings provide a clear indication that these programmes are effective when used in care homes.
We have recently completed an randomised controlled trial of more than a 1000 people with dementia in 70 care homes to evaluate the efficacy of this optimized intervention (person-centred care plus social interaction and antipsychotic review). This is the largest evaluation ever completed of a non-pharmacological intervention in people with dementia. Results are expected soon.
This study recruited care homes through the BRU Care Home Research Network. This core infrastructure was critical to its success.
The work is now moving into a phase of dissemination to ensure the findings of this study are implemented in practice. This includes running GP workshops and webinars (approved by the Royal College of General Practitioners), a British Medical Journal (BMJ) training module and an updated Department of Health / Alzheimer’s Society best practice guide for Behavioural and Psychological symptoms in dementia. We are updating national guidance on the management of behavioural symptoms, and we are also working with care homes to make sure that the final package of care is best suited to their needs.
This work is therefore moving into a space where people with dementia in care homes will experience a direct benefit, and care home staff will have better training and support for their caring role. Furthermore, by improving antipsychotic review this intervention has the potential to keep antipsychotic prescribing levels low, thus reducing costs and improving overall health of residents.
Our successful randomised controlled trial of pimavanserin, a novel treatment for psychosis in Parkinson’s Disease has now been published in The Lancet. The trial showed that pimavanserin is both safe and effective in this patient group and we are currently actively participating in submissions for regulatory approval, including a new drug application to the US Food and Drug Administration (FDA)
We also are now hosting a phase III trial of pimavanserin in people with Alzheimer’s Disease, recruited through the BRU Care Home Research Network. This work represents effective translation of novel findings across disease states, and provides the opportunity for a novel treatment with a far better safety profile than the existing antipsychotic medications. The implications for people with dementia and psychosis are substantial. It is hoped that pimavanserin will soon be available for use in practice as a viable alternative to atypical antipsychotics.
The pimavanserin trial also used novel methodology to reduce placebo response rates, a major problem in randomised controlled trials of neuropsychiatric symptoms in people with dementia. BRU Theme Leads developed a brief psychosocial therapy adapted for Parkinson's disease to help elicit a placebo response ahead of the drug administration. The psychosocial therapy consisted of daily social interactions between participant and caregiver based on a plan tailored to their interests and capabilities. This approach has been approved and commended by the FDA and literature reviews by leading European and North American groups and has been used in the recent high impact CITAD study examining the treatment of agitation in people with AD using citalopram in the US. We have been involved in advisory board and partnership discussions with other pharmaceutical companies who are interested in using our brief psychosocial therapy approach in future trials.
Research carried out by NIHR Maudsley Dementia Biomedical Research Unit (BRU) academics and funded by Alzheimer’s Society found that an online brain training package can not only improve memory and reasoning skills – but also how well older people carry out everyday tasks such as navigating public transport, shopping, cooking and managing personal finances.
Previous research has shown that brain training programs might have some potential to memory, although these small-scale studies were inconclusive. Our research is the largest randomised control trial to date of an online brain training package. Involving almost 7,000 adults aged over 50, it is also the first to evaluate the impact of computerised brain training on how well people can perform their daily activities.
The brain training package comprised three reasoning tasks, such as balancing weights on a see-saw, and three problem-solving tasks, such as putting numbered tiles in numerical order. Study participants (initially recruited from the general population through a partnership between the BBC, Alzheimer’s Society and the Medical Research Council) were encouraged to play the game for 10 minutes at a time, as often as they wished. Before starting the study and again after six weeks, three months and six months, the participants completed a series of cognitive tests, including measures of grammatical reasoning and memory. Those over 60 were also assessed on a test of daily living (e.g. using the telephone, navigating public transport and doing the shopping).
After six months, brain training led to significant improvements in scores on the test of daily living in people over 60, and significant improvement in reasoning and verbal learning in those over 50, compared to those who didn’t play the reasoning and problem solving games. Playing the brain training games five times per week was most effective in bringing about these improvements.
This new study could have important implications for preserving cognitive function in older adults and might offer an effective, easily accessible intervention to help people reduce their risk of cognitive decline later in life.
We coordinated the publication of this study in JAMDA with the public launch of a new online brain training trial to see how well older people engage with the brain training package over the long-term. This new study will also investigate how genetics might affect performance to allow us to better understand how brain training could be used to maintain cognition or even reduce the risk of cognitive decline and dementia. The new trial is nested within the 10 year PROTECT study which will gather data and improve our understanding of the brain and why people develop dementia.
The huge amount of national media coverage that we gained for the JAMDA paper and launch of the new brain training research helped us achieve the fantastic result of 17,000 people recruited to the brain training study within one week.