Blog – The Role of Memory Clinics in Clinical Research

The assessment of memory and a person’s ability to undertake activities of daily living is central to the conduct and potential success of clinical trials. The assessment of memory and daily living skills, albeit often less intensively, is central to the ability to make an appropriate diagnosis of cognitive impairment. So, the foundation for clinical practice and for clinical trial work has much in common.

Despite this, there is often a feeling amongst clinicians (not only doctors) that clinical trials are something of a mystery, requiring different skills from clinical practice, and a special setting for their conduct. While to some extent this idea has credence – clinical trials involve much more intensive assessment of people than normal clinical practice – the consequent assumption is that all aspects of clinical trial work need special settings, often termed Specialist Memory Clinics. Yet even these vary in what they do. Some, predominantly private enterprises, focus on intensively assessing people with a view to recruiting them into trials but not integrating with NHS or social services providing on-going care and management of the same person. Within the NHS, the Royal College of Psychiatrists Memory Services National Accreditation Programme (MSNAP) provides an extensive list of minimal through to aspirational standards which services seeking accreditation are evaluated against. At a basic level, the service (should provide) patients and their carers with information about adding their details to a research participation register and opportunities to participate in local, national and international research, though specific knowledge about the Join Dementia Research (JDR) Database (including the registration procedure) and any local dementia research projects might be seen as more aspirational, even though the availability of JDR Learn could help staff with this task.

The next argument presented by clinicians is that the method of assessing memory and function used in Memory Clinics is too detailed to be used in mainstream clinical practice and is at times idiosyncratic. Again, to some extent, this is true. However many clinical trial sponsors from the pharmaceutical industry also have their own unique mixture of scales used in their trials, depending on what properties of the drug in question they feel will give them valuable results. Nonetheless, there is quite a bit of overlap between the scales used in mainstream services and those used in Memory Clinics. Most mainstream services will use a basic, short, assessment scale like the Mini-Mental State Examination (MMSE) which is also used in Memory Clinics and in clinical trials in the field of dementia. Therefore at the most basic level staff in Memory Clinics can liaise with mainstream services to indicate what level of impairment on the MMSE is currently of interest to sponsors of clinical trials, and encourage referrals.

To make more of this overlap, there is an educational role for those working in a Memory Clinic environment who have opportunities to inform staff in mainstream services about the more intensive assessment measures they use, which encourages mainstream services to focus on key questions which they can use in their own assessment of activities of daily living, behavioural change or other deficits associated with the development of dementia which should promote more targeted referrals to Memory Clinics. In addition, education in the manipulation and interpretation of CT and MRI scans can help the making of an appropriate diagnosis easier, and again promote more appropriate referrals to Memory Clinics, should these be separate from mainstream services.

In some cases, direct referral from GPs to Memory Clinics is the norm. Here there should be a clearer appreciation of what clinical trials are being conducted in their region and what criteria are being used to assess suitability for participation in those trials. In other cases, including those clinics in the private sector, the Memory Clinics are conducting clinical trials on the premises. In each of these cases, referral from the clinic to the trial centre should be more seamless than if the assessments are being conducted in mainstream services. The Memory Clinic may maintain its own register of potential participants, as well as routinely using nationally available sources such as JDR. Memory Clinics would be expected to access CT and/or MRI more routinely, and may be able to access more detailed radiographical investigations such as Amyloid PET scans.

Thereafter, it might be expected that Memory Clinics would participate in clinical trials, either directly within their own premises and with their own staff, or indirectly through regular liaison with specialist Trial Centres.

So, although there are many models for the assessment of people with changes in their cognition and daily function, there is a pathway from initial assessment through to participation in clinical trials, of which Memory Clinics can play a central part, at a basic level by liaison and education of staff in mainstream services, and by direct or indirect participation in clinical trials. It is a pathway which can work very effectively and should be used more often.

Dr Peter Connelly

Author

Dr Peter Connelly is a retired Old Age Psychiatrist who spent much of his career in Tayside, helping to establish clinical trials for dementia and neuroprogressive disorders in Scotland. Now working with the Scottish Neuroprogressive and Dementia Network, he combines professional insight with personal experience as a former carer. In retirement, he enjoys music, golf, and time with his grandchildren.