DARWIN EU® - Alzheimer’s Disease: Incidence, Prevalence, and Individuals' Characteristics

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:
  Objective 1: All individuals aged 18 years or older present in the data sources during the study period from ; 01/01/2014 to 31/12/2024, or earliest date of loss to follow-up, death, end of the observation period or ; data availability, or the earliest date of AD diagnosis with at least 365 days of database history. ; Objective 2: All individuals with newly (incident) diagnosed AD aged 18 years or older, diagnosed with AD ; during the study period from 01/01/2014 to 31/12/2024, with at least 365 days of database history.
• 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:
  • Population level cohort study (objective 1); • Patient level cohort study (objective 2)
• Main study objective:
  1. To estimate overall incidence and prevalence of Alzheimer's disease in the general population and stratified by calendar year, sex, and age. ; 2. To describe the demographic characteristics, diagnostic procedures, and clinical profile of individuals with newly-diagnosed AD.
• Data analysis plan:
  Objective 1: Yearly incidence rates per 100,000 person-years and prevalence of AD will be estimated, ; overall and stratified by calendar year, sex, and age categories. Incidence rates and prevalence will be ; reported with 95% confidence intervals. ; Objective 2: Demographic characteristics, pre-specified comorbidities, concomitant medications, diagnostic ; procedures, and prior cognitive diagnosis will also be described and will be reported as counts and ; proportions. For MCI, time from MCI recording to AD diagnosis will be described as well. ; A minimum cell count of 5 will be used when reporting results, with any smaller count reported as “<5” and ; zero counts as “0”.