Table 2.
Summary of patients in placebo groups from eight placebo-controlled randomized trials targeting AD
| AD severity |
Mild to moderate |
Severe |
||||||
|---|---|---|---|---|---|---|---|---|
| Trial name | EIS-161 | JPN-3 | MA3301 | JPN-5 | D1301 | IE2101 | EIS-231 | IE3501 |
| Company name | Eisai | Janssen | Daiichi-Sankyo | Janssen | Novartis/Ono | Daiichi-Sankyo | Eisai | Daiichi-Sankyo |
| Total number of patients | 129 | 136 | 180 | 194 | 268 | 107 | 102 | 208 |
| Trial period | 1996–1998 | 2001–2003 | 2003–2007 | 2006–2008 | 2007–2008 | 2002–2004 | 2003–2004 | 2005–2008 |
| Visit (weeks) | −4, 0, 4, 8, 12, 16, 20, 24 | −4, 0, 12, 22 | −4, 0, 4, 12, 24 | −4, 0, 8, 12, 16, 24 | 0, 8, 16, 24 | 0, 4, 12, 24 | 0, 8, 16, 24 | 0, 4, 12, 24 |
| ADAS-cog | + | + | + | + | + | − | − | − |
| SIB | - | - | - | - | - | + | + | + |
| MMSE | + | + | + | + | + | + | + | - |
| CDR | + | - | + | - | - | - | - | - |
| CIBIC plus | - | + | + | + | + | + | + | + |
| DAD | - | + | + | + | + | + | - | - |
| BEHAVE-AD | - | + | - | + | + | + | + | + |
| MENFIS | + | + | - | + | + | + | - | + |
| ADCS-ADL | - | - | - | - | - | + | + | - |
| Laboratory data | + | + | + | + | + | + | + | + |
| Vital sign | + | - | + | - | + | + | + | + |
Abbreviations: AD, Alzheimer's disease; ADAS-cog, Alzheimer's Disease Assessment Scale-cognitive subscale; SIB, Severe Impairment Battery; MMSE, Mini-Mental State Examination; CDR, Clinical Dementia Rating; CIBIC plus, Clinician's Interview-Based Impression of Change plus caregiver input; DAD, Disability Assessment for Dementia; BEHAVE-AD, Behavioral pathology in Alzheimer's Disease; MENFIS, Mental Function Impairment Scale; ADCS-ADL, Alzheimer's disease Cooperative Study-ADL scale; +, present; -, absent.