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Table 3 Change from baseline in patient and caregiver outcomes at 18 months (propensity score-adjusted)

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 LS mean (95% CI) change from baseline Difference (95% CI) ANCOVA p value for study type
EXPEDITION RCTs (EU population) GERAS observational study
ADAS-Cog14 score 6.73 (4.68, 8.79) 4.92 (3.49, 6.35) 1.81 (−0.30, 3.92) 0.09
ADCS-ADL basic score −1.80 (−2.54, −1.06) −1.80 (−2.29, −1.30) −0.00 (−0.76, 0.75) 0.99
ADCS-ADL instrumental score −7.42 (−9.45, −5.39) −7.29 (−8.64, −5.94) −0.13 (−2.22, 1.96) 0.90
EQ-5D UK population-based index score −0.036 (−0.087, 0.015) −0.069 (−0.103, −0.034) 0.032 (−0.020, 0.085) 0.22
EQ-5D VAS score −0.60 (−4.41, 3.21) −2.11 (−4.92, 0.70) 1.51 (−2.42, 5.44) 0.45
NPI-12 Caregiver Distress score 1.79 (0.51, 3.07) 1.90 (1.13, 2.68) −0.11 (−1.49, 1.27) 0.90
  1. Poorer cognition is indicated by higher scores for ADAS-Cog14; poorer functioning is indicated by lower ADCS-ADL basic and instrumental scores; reduced HRQoL is indicated by lower EQ-5D scores; greater caregiver distress is indicated by higher NPI-12 Caregiver Distress scores
  2. ADAS-Cog14 14-item cognitive subscale of the Alzheimer’s Disease Assessment Scale, ADCS-ADL Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory, ANCOVA analysis of covariance, CI confidence interval, EQ-5D EuroQoL-5-Dimensions questionnaire, EU European, LS least squares, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory, RCT randomised controlled trial, UK United Kingdom, VAS visual analogue scale