Table 1.
Baseline demographics
| 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) |
aComposite of Category Fluency Test and Controlled Oral Word Association Test
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