Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

Jones, Roy; Wilkinson, David; Lopez, Oscar L; Cummings, Jeffrey; Waldemar, Gunhild; Zhang, Richard; Mackell, Joan; Gauthier, Serge

doi:10.1186/1745-6215-12-233

Trials

Table 1 Donepezil AD data repository summary (randomised, controlled trials only)

From: Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease

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		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		1997
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

*1 = Jones RW et al [2]; 2 = Wilkinson D et al [3]; 3 = Gauthier S et al [4]; 4 = Cummings J et al [5]; 5 = Lopez O et al [6]; 6 = Waldemar G et al [7].
MMSE = Mini-Mental State Examination, EWG = Expert Working Group, ADAS-cog = Alzheimer's Disease Assessment Scale-cognitive subscale, ApoE = apolipoprotein E, SIB = Severe Impairment Battery, AD = Alzheimer's disease, DB = double blind.

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ISSN: 1745-6215

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