Skip to main content

Table 3 MMRM results for selected secondary and exploratory endpoints at week 12 (visit 5)

From: A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer’s disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil

Endpoint

Treatment group

n

LS mean (SE)

80% CI

Difference (SE)

80% CI for difference

Two-sided P value

NPI total

SAM-760

78

−3.99 (1.24)

−5.59, −2.40

2.19 (1.71)

−0.01, 4.40

0.20

Placebo

87

−6.18 (1.18)

−7.70, −4.67

ADAS-cog11

SAM-760

78

0.26 (0.55)

−0.44, 0.97

0.65 (0.76)

−0.32, 1.62

0.39

Placebo

87

−0.39 (0.52)

−1.05, 0.28

ADCS-ADL

SAM-760

65

−0.69 (0.82)

−1.75, 0.37

0.82 (1.13)

−0.64, 2.28

0.47

Placebo

72

−1.51 (0.78)

−2.51, −0.50

CSDD

SAM-760

79

−1.41 (0.34)

−1.85, −0.97

− 0.59 (0.47)

−1.19, 0.02

0.22

Placebo

86

−0.82 (0.32)

−1.24, −0.41

CGI-I

SAM–760

80

3.83 (0.12)

3.68, 3.98

−0.03 (0.16)

−0.23, 0.18

0.87

Placebo

86

3.86 (0.11)

3.71, 4.00

MMSE

SAM-760

80

0.43 (0.29)

0.05, 0.80

−0.38 (0.40)

−0.90, 0.13

0.34

Placebo

88

0.81 (0.28)

0.45, 1.16

  1. ADAS-cog11 Alzheimer’s Disease Assessment Scale-cognitive subscale, ADCS-ADL Alzheimer’s Disease Cooperative Study-Activities of Daily Living, CGI-I Clinician’s Global Impression of Improvement, CSDD Cornell Scale for Depression in Dementia, MMRM mixed model repeated measures, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory