Alzheimer’s disease (AD) is an age-related disorder, characterised by memory loss that gets worse over time. Patients present with behavioural symptoms, including repetitive behaviour and confusion and ultimately struggle to perform normal activities required for daily living. These include cooking and washing, and so eventually, patients lose the ability to live independently and ultimately die with the disease. AD and dementia are the leading cause of death in the UK.
There is currently no cure for the disease, with current treatments aiming to promote independence, maintain function and treat symptoms. Newly developed treatments, amyloid targeting therapies (ATTs), target the protein that forms around braincells and is a hallmark of the disease, resulting in a slowing of disease progression. When they are rolled out across the UK (anticipated 2024), it will be advised that patients require an AD diagnosis by specific tests to receive them. Currently, most patients are not diagnosed with these tests and are diagnosed when the disease is more severe, leading to poorer patient outcomes. It is hoped that the launch of these treatments and subsequent changes in diagnosis guidelines will improve this.
This study aims to monitor and describe the change in patient care following their AD diagnosis. Patient demographics and characteristics, time waiting for treatments, frequency of follow-up appointments, treatments used, disease progression, death rates, moves to assisted living, and use of healthcare resources will be assessed over the next three years to help to identify ways in which care can be improved in the future.
Aim: To describe the current and future state of AD diagnosis and disease management in the National Health Service (NHS) in England. Results from this study will be used to assess how the standard of care for AD patients in England undergoes change for the effective introduction of amyloid targeting therapies (ATTs) as a treatment option.
Objectives: To describe: i) sociodemographic and clinical characteristics; ii) AD disease management; iii) disease progression, mortality and moves to assisted living; iv) healthcare resource utilisation (HCRU) and related costs; v) comorbid conditions; vi) proportion of patients with a biomarker confirmed diagnosis; vii) time from presentation of symptoms to diagnosis and disease progression in patients with AD.
Methods: Retrospective cohort study of adults newly diagnosed with AD within three successive time periods (waves) to capture how care changes during and after ATT launch. Patients will be indexed across a 6-month period and followed-up over a variable (6-12-month) period. The first wave will occur between March 2022 and March 2023, with the second and third waves likely to occur over the following two years without overlap. Primary (CPRD Aurum) and secondary (HES) will be used to assess aims and objectives.
Exposures: AD diagnosis and AD severity.
Outcomes: Sociodemographic and clinical characteristics, time to treatment, treatment patterns, frequency of follow-up appointments, time to receive diagnostic/imaging procedure, disease progression, mortality, moves into assisted living, HCRU and related costs, comorbid conditions, proportions of patients with biomarker confirmed AD diagnosis, time from initial presentation of symptoms to first AD diagnosis.
Data analysis: Frequencies and percentages will be reported for categorical variables. Counts, means, medians and standard deviations will be reported for continuous variables. Kaplan-Meier plots and associated statistics will be reported for time-to event variables. Incidence rate will be calculated by dividing frequency of events by person time at-risk.
Sociodemographics (age, sex, geographic region, socioeconomic status, ethnicity, smoking status, education level, marital status, employment status) and clinical characteristics (family history of AD, Charlson Comorbidity Index (CCI), symptoms, body mass index (BMI), caregiver); time to pharmacological treatment; pharmacological treatment patterns (including off-label treatment use); frequency of follow-up appointments; time to receive diagnostic/imaging procedure; disease progression; mortality; HCRU and related costs; comorbid conditions; proportion of patients referred for and in receipt of biomarker confirmed diagnosis; time from initial presentation of AD symptoms to AD diagnosis
Caroline Casey - Chief Investigator - Eli Lilly and Company Ltd. (UK)
Amisha Patel - Corresponding Applicant - Adelphi Real World
Beth Dibben - Collaborator - Adelphi Real World
Lucinda Camidge - Collaborator - Adelphi Real World
Lucy Massey - Collaborator - Adelphi Real World
Niraj Patel - Collaborator - Eli Lilly & Co - UK
Nuha Brookfield - Collaborator - Eli Lilly and Company Ltd. (UK)
HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation