Treatment patterns and burden of agitation in patients with Alzheimer's disease in the UK

Date of ISAC Approval: 
Lay Summary: 
Alzheimer's disease (AD) is the most common cause of dementia in the UK and symptoms can include memory loss and difficulties with thinking, problem-solving or language. Over time, more symptoms develop and many people develop behaviours that seem out of character. These can include agitation (e.g. restlessness, pacing), depression, anxiety, delusions, hallucinations and sleep disturbances. Agitation is a common symptom; in nursing homes, over 50% of people with AD are estimated to experience agitation. Agitation and other behavioural symptoms are treated with antipsychotics (APs), medicines traditionally used to treat psychiatric illness such as schizophrenia. There is currently little information on how these medicines are used in treating the symptoms of AD. We propose to use routinely collected health information from the Clinical Practice Research Datalink to understand the use of APs for treatment of agitation in AD. We will determine patients with AD and describe and compare the use of AP among people with no behavioural symptoms, those with agitation and those with other behavioural symptoms. We will also describe changes over time in the use of APs (2004 to 2017). This information will help to understand the current clinical management of behavioural symptoms in AD.
Technical Summary: 
Background: Antipsychotics (APs) are used in the treatment of neuropsychiatric symptoms (NPS) of Alzheimer's disease (AD). Despite newer atypical APs having improved safety profiles compared to older typical APs, severe adverse effects remain and there is a drive to reduce AP use in dementia. Evidence on AP use for NPS in patients with AD is lacking. Objectives: This study will describe the use and treatment patterns of APs for NPS, specifically agitation, a common symptom in patients with AD. Methods: People with AD will be identified between 1 April 2004 and 31 December 2017. 1) Prescribing rates and treatment patterns for different AP types will be described in two recent time windows (2017 and 2015-2017) for patients classified into NPS descriptive cohorts. 2) Changes over time will be assessed by describing rates and patterns in each calendar year of the study period. 3) Patient characteristics will be described and compared across NPS descriptive cohorts 4) Treatment patterns will be compared across NPS groups for the recent time window (2015-2017). Importance: This valuable up-to-date information, in a large number of people with AD, identified from a representative UK population, will help understand the current clinical management of dementia and NPS.
Health Outcomes to be Measured: 
Number of patients prescribed antipsychotic (AP) therapy during each calendar year Prescribing rates of APs and other psychotropic drugs Total days of AP supply per person-year Number of AP prescriptions Dose of initial risperidone prescription and highest dose of all risperidone prescriptions Number of patients with a referral for non-pharmacological treatment Adherence to APs Persistence to APs

Kristian Tore Jorgensen - Chief Investigator - Lundbeck Limited
Lucy Tran - Collaborator - OXON Epidemiology
Martin Bog - Collaborator - Lundbeck Limited
Michelle Johnson - Corresponding Applicant - Roche
Dr Nawab Qizilbash - Collaborator - OXON Epidemiology