Table 5.

Changes in clinical outcome scores that indicate clinically important difference, by disease severity, and change in global CDR (n = 48,254 pairs of visits)

Clinical outcome	Overall		Normal		MCI-AD		Mild AD dementia		Moderate-severe AD dementia
	Change from 0.5 to 1 (N = 2924)	No change (N = 45,330)	Change from 0.5 to 1 (N = 220)	No change (N = 23,622)	Change from 0.5 to 1 (N = 918)	No change (N = 6420)	Change from 0.5 to 1 (N = 1171)	No change (N = 5118)	Change from 0.5 to 1 (N = 139)	No change (N = 1542)
MMSE
Mean change (95% CI)	−2.58 (−2.71; −2.45)	−0.46 (−0.48; −0.44)	−2.79 (−3.24; −2.33)	−0.11 (−0.13; −0.10)	−2.55 (−2.76; −2.34)	−0.72 (−0.78; −0.66)	−2.36 (−2.55; −2.16)	−1.63 (−1.72; −1.54)	−4.99 (−5.77; −4.22)	−2.15 (−2.33; −1.98)
ES	−0.73	−0.10	−0.97	−0.10	−0.86	−0.23	−0.80	−0.38	−1.12	−0.33
SRM	−0.72	−0.21	−0.81	−0.09	−0.80	−0.29	−0.69	−0.51	−1.08	−0.60
½ SD(baseline)	1.76	2.19	1.44	0.56	1.48	1.54	1.48	2.12	2.23	3.30
FAQ
Mean change (95% CI)	6.25 (6.02; 6.49)	0.72 (0.69; 0.75)	6.32 (5.38; 7.26)	0.14 (0.12; 0.16)	6.92 (6.50; 7.34)	1.42 (1.32; 1.51)	5.68 (5.34; 6.01)	2.44 (2.30; 2.57)	8.42 (7.12; 9.71)	2.08 (1.81; 2.35)
ES	1.01	0.10	0.94	0.05	1.14	0.22	0.98	0.29	1.36	0.24
SRM	0.97	0.22	0.89	0.08	1.06	0.36	0.98	0.50	1.09	0.38
½ SD(baseline)	3.08	3.78	3.35	1.37	3.04	3.24	2.89	4.25	3.09	4.41

NOTE.

• 1.
  Effect size was calculated at the visit level as the mean difference in score divided by SD_(baseline).
• 2.
  SRM was calculated at the visit level as the mean difference in score divided by SD of the change from previous visit score.
• 3.
  1/2 SD_(baseline) was calculated at the visit level as 0.5 x SD_(baseline).

Abbreviations: AD, Alzheimer's disease; CDR, Clinical Dementia Rating; CI, confidence interval; ES, effect size; FAQ, Functional Assessment Questionnaire; MCI, mild cognitive impairment; MMSE, Mini Mental State Examination; SRM, standardized response mean; SD, standard deviation.