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

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

Outcome	LS mean (95% CI) change from baseline		Difference (95% CI)	ANCOVA p value for study type
Outcome	EXPEDITION RCTs (EU population)	GERAS observational study	Difference (95% CI)	ANCOVA p value for study type
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

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
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

ISSN: 1758-9193