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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