Skip to main content

Advertisement

Table 2 Baseline patient and caregiver outcomes

From: Representativeness of European clinical trial populations in mild Alzheimer’s disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study

Outcome EXPEDITION RCTs (EU population) GERAS observational study p value for unadjusted baseline comparison
Patients, N 168 566  
 ADAS-Cog14 score (range 0–90 [11,12]) 29.4 (8.6) 30.4 (7.8) 0.16
 ADCS-ADL basic score (range 0–22 [13]) 20.6 (2.5) 19.8 (3.1) 0.005
 ADCS-ADL instrumental score (range 0–56 [13]) 42.5 (9.9) 38.5 (11.8) < 0.001
 NPI-12 total score (range 0–144 [14,15]) 12.0 (12.8) 10.2 (10.7) 0.07
 EQ-5D UK population-based index score (range 0–1 [16]) 0.79 (0.18) 0.71 (0.24) < 0.001
 EQ-5D VAS score (range 0–100 [16]) 62.2 (24.1) 66.0 (18.5) 0.03
Caregivers, N 168 566  
 NPI-12 Caregiver Distress score (range 0–60 [15]) 7.1 (7.1) 6.4 (6.2) 0.26
 Caregiver time spent on patient (hours in past month)
  Basic ADL, mean (SD) 9.8 (26.9) 16.4 (44.7) 0.009
   Median (IQR) 0 (0–0) 0 (0–15)  
  Instrumental ADL, mean (SD) 53.5 (61.9) 61.0 (83.1) 0.23
   Median (IQR) 30 (2–90) 36 (8–90)  
  Supervision, mean (SD) 24.9 (89.1) 48.4 (123.6) < 0.001
   Median (IQR) 0 (0–0) 0 (0–30)  
  Overall, mean (SD) 86.3 (128.5) 121.6 (174.2) 0.01
   Median (IQR) 30.6 (3–120) 60 (15–125)  
  1. Data presented as mean (standard deviation) unless stated otherwise. Missing data ranged from one to three participants in the EXPEDITION trials and from one to eight participants in the GERAS study. p-values in bold represent a significant difference between EXPEDITION and GERAS
  2. Poorer cognition is indicated by higher scores for ADAS-Cog14; poorer functioning is indicated by lower ADCS-ADL basic and instrumental scores; poorer neuropsychiatric function is indicated by higher NPI-12 scores; reduced HRQoL is indicated by lower EQ-5D scores; greater caregiver distress is indicated by higher NPI-12 Caregiver Distress scores
  3. ADAS-Cog14 14-item cognitive subscale of the Alzheimer’s Disease Assessment Scale, ADL activities of daily living, ADCS-ADL Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory, EQ-5D EuroQoL-5-Dimensions questionnaire, EU European, HRQoL health-related quality of life, IQR interquartile range, NPI Neuropsychiatric Inventory, RCT randomised controlled trial, SD standard deviation, UK United Kingdom, VAS visual analogue scale