DARWIN EU® - Treatment characterisation and post-diagnosis outcomes in Alzheimer’s disease

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Dementia Alzheimer's type

Population studied

• Short description of the study population:
  The study population for objectives 1 and 5b will include individuals with incident AD and with AD treatment initiation between 01/01/2014 and 31/12/2023.The study population for objectives 2, 3b, 4a–b, 4d, and 5a will include individuals in the data source with incident AD, defined as a first diagnosis of AD between 01/01/2014 and 31/12/2023 with at least 365 days of database history prior to the date of the first diagnosis of AD (index date) and aged ≥18 years at index date. The study population for objective 3a will include individuals with incident AD between 01/01/2014 and 31/12/2023 and no history of AD treatment prior to the first diagnosis of AD. The study population for objective 4c will include individuals with incident AD between 01/01/2014 and 31/12/2023 and no history of caregiver support prior to the first diagnosis of AD.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This study will be conducted using routinely collected data from five primary/secondary care data sources in the DARWIN EU® network of data partners from four European countries
• Main study objective:
  Objective 1. To characterise treatments received by individuals newly diagnosed with Alzheimer’s disease, in the year, three, and five years following diagnosis. ; Objective 2. To describe the timing and frequency of relevant clinical and care-related events following Alzheimer’s disease diagnosis, including (when available):; Hospitalisations at fixed time points (e.g., 1-, 3-, and 5-years post-diagnosis); Healthcare system utilisation (number of outpatient visits at 1-, 3-, and 5-years post-diagnosis); Time to first record of caregiver support; Time to nursing home or hospice admission; Death at fixed time points (e.g., 1-, 3-, and 5-years post-diagnosis); Objective 3. To describe time to death from first initiation of treatment following Alzheimer’s disease diagnosis
• Setting:
  This study is be conducted using routinely collected data from five primary/secondary care data sources in the DARWIN EU® network of data partners from four European countries
• Outcomes:
  prescription of a pharmacological treatments for AD (objectives 2 and 3), occurrence of clinical and care-related events (objective 4), and survival (objective 5). The pharmacological treatments of interest are acetylcholinesterase inhibitors (donepezil, rivastigmine, and galantamine), memantine, and antipsychotics. The clinical and care-related events of interest are hospitalisation, outpatient visit, and caregiver support.