Study identifier | Phase | Disease stage/MMSE range | Donepezil/placebo dose, mg | Duration (weeks) | Study objective for donepezil | Total patient number (donepezil + placebo) | Cognitive efficacy measure | Period of study | EWG study* |
---|---|---|---|---|---|---|---|---|---|
201 [8] | 2 | Mild to moderate/10-26 | 1, 3, 5 | 12 | Initial study of efficacy and safety | 150 | ADAS-cog MMSE | 1991-1992 | 1, 3, 5 |
301 [9] | 3 | Mild to moderate/10-26 | 5, 10 | 12 | Pivotal study of efficacy and safety (USA) | 476 | ADAS-cog MMSE | 1993-1994 | 1, 5 |
302 [9] | 3 | Mild to moderate/10-26 | 5, 10 | 24 | Pivotal study of efficacy and safety (USA) | 471 | ADAS-cogMMSE | 1993-1994 | 1, 2, 5 |
304 [10] | 3 | Mild to moderate/10-26 | 5, 10 | 24 | Pivotal study of efficacy and safety (Europe) | 816 | ADAS-cog | 1994-1996 | 1, 3, 5 |
134 [11] | 2 | Mild to moderate/10-26 | 3, 5 | 12 | Efficacy and safety (Japan) | 190 | ADAS-cog | 1994 | 5 |
161 [12] | 3 | Mild to moderate/10-26 | 5 | 24 | Efficacy and safety (Japan) | 268 | ADAS-cog | 1996-1999 | 1, 5 |
203 [13] | 2 | Mild to moderate/10-26 | 10 | 24 | Effects on regional brain glucose metabolism | 28 | ADAS-cog | 1996-1997 | 1, 5 |
204 [14] | 2 | Mild to moderate/10-26 | 10 | 24 | Effects on hippocampal volume and neuron integrity | 67 | ADAS-cog | 1996-1997 | 1, 5 |
205 [15] | 2 | Mild to moderate/10-26 | 10 | 52 | Effects on visuospatial awareness | 11 | MMSE | 1996-1997 | 1, 5 |
306 [11] | 3b | Â | 10 | 12 | ApoE subtype and response | 38 | MMSE | 1997-1998 | 1, 5 |
311 [16] | 3b | Mild to severe/5-26 | 10 | 24 | Efficacy and safety in nursing home patients | 208 | MMSE | 1996-1997 | 1, 3, 5 |
312 [17] | 3b | Mild to moderate/12-20 | 10 | 54 | Preservation of function | 431 | MMSE | 1996-1997 | 1, 3, 5 |
324 [18] | 3b | Moderate to severe/5-18 | 10 | 24 | Efficacy and safety in moderate to severe AD | 290 | MMSE, SIB | 1996-1998 | 1, 2, 3, 4, 5, 6 |
33301 | 3b | Mild to moderate/18-26 | 10 | 12 | Effect on attention | 296 | Â | 1997 | Â |
96001 [19] | 3b | Mild to moderate/10-26 | 10 | 52 | 1-year DB efficacy and safety | 286 | MMSE | 1997 | 1, 2, 3, 5, 6 |
231 [20] | 4 | Severe/1-12 | 10 | 24 | Efficacy and safety in severe AD | 343 | SIB | 2001-2005 | 4 |
315 [21] | 4 | Severe/1-12 | 5, 10 | 24 | Efficacy and safety in severe AD (Japan) | 248 | SIB | 2002-2005 | 4 |
1017 [22] | 4 | Severe/1-10 | 10 | 24 | Efficacy and safety in severe AD | 302 | SIB | 2002-2004 | 4 |