Patient-centred care, without the use of medicines is offered as a first course of treatment for agitation in dementia. However, there is a need for second line treatments when these fail, at the moment antipsychotics are commonly prescribed, as very little research has been done in to safer alternative treatments.
There are medicines available to treat agitation and/or aggression in dementia, but it is not clear which treatments work best.
This research study has been designed to help answer this, by comparing 2 medicines with a placebo (a tablet designed to look like a medicine but that has no active medicine in it) to see if either are suitable for treating agitation in dementia.
The medicines that will be tested are Mirtazapine and Carbamazepine.
If patients and their family/carers agree to take part in this study, they will be prescribed treatment for 12 weeks. They will then be followed up for 1 year after, with assessment sessions at 26 and 52 weeks.
Patients taking part in this study will be randomly allocated to a treatment group (they will be selected to their treatment group by chance). The study is blinded, so this means their doctor and the research team will not know which treatment they have been taking until after the study has ended. This is necessary so that the trial is a fair test of which treatment works best, however it is possible to find out which medicine they are taking in the event of a medical emergency.
The study is entirely voluntary and all patients wishing to join the study must complete an informed consent form (or if they lack capacity their representative may do so on their behalf). Each participant must also have a nominated carer who consents to being questioned on aspects of the patient’s dementia/care and their own experiences in caring for the patient.
We are aiming to recruit 471 patients to the study in total from 8 different regions across the UK.
Further information on this study is available from Join Dementia Research and their website also gives further information should you or a relative wish to participate in a dementia research study.