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Table 1 Baseline demographics

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

 

SAM-760 30 mg QD (n = 92)

Placebo

(n = 94)

Male, n (%)

46 (50.0)

39 (41.5)

Mean age, years (SD)

76.0 (8.0)

75.9 (7.5)

Mean weight, kg (SD)

72.4 (13.3)

70.8 (15.4)

Mean body mass index, kg/m2 (SD)

26.8 (4.6)

26.8 (4.3)

Mean height, cm (SD)

164.4 (9.6)

161.8 (11.1)

Mean duration since AD diagnosis, years

2.8

2.9

MMSE score mild (20–24), n (%)

53 (57.6)

47 (50)

MMSE score moderate (10–19), n (%)

39 (42.4)

47 (50)

Mean total MMSE score (SD)

19.7 (4.2)

19.6 (4.0)

Mean ADAS-cog13 score (SD)

34.9 (14.8)

33.2 (12.7)

Mean NPI score (SD)

21.1 (12.4)

21.8 (11.9)

Mean ADAS-cog11 score (SD)

25.7 (12.4)

24.1 (10.6)

Mean ADCS-ADL score (SD)

57.8 (13.7)

57.7 (15.7)

Mean CGI-I score (SD)

3.8 (0.8)

3.6 (0.6)

Mean CSDD score (SD)

5.9 (4.3)

5.3 (3.6)

Mean executive function composite score (SD)a

−0.1 (0.1)

0.1 (0.1)

ApoE4 genotype, n (%)

  

 E2/E4

2 (2.2)

2 (2.2)

 E3/E4

37 (40.1)

41 (44.6)

 E4/E4

7 (7.7)

4 (4.4)

  1. aComposite of Category Fluency Test and Controlled Oral Word Association Test
  2. AD Alzheimer’s disease, ADAS-cog13/11 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, CFT Category Fluency Test (executive function), COWAT Controlled Oral Word Association Test, MMSE Mini-Mental State Examination, NPI Neuropsychiatric Inventory, QD once daily, SD standard deviation