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© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.2 TABLE 1. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be TABLE 1. Studies Included in the AnalysesStudy references: group 1: 201,9 301,10 302,11 and ; group 2: 161,13 203,14 204,15 205,16 306,17 311,18 312,19 324,20 and *Represents scheduled assessments for relevant cognitive efficacy measure(s).+Includes only patients with baseline MMSE scores of 10 to 26 (inclusive).++Studies included in group 1, pre-1995.[S]Studies included in group 2, post-1995.AD indicates Alzheimer disease; ADAS-cog, Alzheimer's disease assessment scale-cognitive subscale; DB, double blind; MMSE, Mini-Mental State Examination.

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.3 TABLE 2. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be TABLE 2. Summary of Demographic CharacteristicsPercentages shown for race and country of origin data are based on population of patients with nonmissing values.*Demographics data were not available for 1 patient from study 301 and 1 patient from study 302 (both pre-1995).+Information on race was not available for 6 patients enrolled in study 324 in group 2 (post-1995).++Country of enrollment information was not available for 157 patients enrolled in study 311 in group 2 (post-1995).ADAS-cog indicates Alzheimer's disease assessment scale-cognitive subscale; MMSE, Mini-Mental State Examination.

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.4 TABLE 3. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be TABLE 3. Medical History

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.5 TABLE 4. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be TABLE 4. Concomitant Medications

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.6 FIGURE 1. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be FIGURE 1. Least squares mean change from baseline on the Mini-Mental State Examination at weeks 12 and 24 for groups 1 and 2 (placebo patients only) for observed case, last observation carried forward, and mixed regression methods. Week 12 results are based on pooled data from patients enrolled in studies of at least 12 weeks, whereas week 24 results are based on pooled data from studies that were 24 weeks or longer. Studies included: group 1 at week 12 data points: 201, 301, and 302; group 2 at week 12 data points: 205, 96001, 324, 311, and 312; group 1 at week 24 data points: 302; group 2 at week 24 data points: 205, 96001, 324, 311, and 312. MR indicates mixed regression; OC, observed case.

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.7 FIGURE 2. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be FIGURE 2. Least squares mean change from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale at weeks 12 and 24 for groups 1 and 2 (placebo patients only) for observed case, last observation carried forward, and mixed regression methods. Week 12 results are based on pooled data from patients enrolled in studies of at least 12 weeks, whereas week 24 results are based on pooled data from studies that were 24 weeks or longer. Studies included: group 1 at week 12 data points: 201, 301, 302, and 304; group 2 at week 12 data points: 203, 204, 306, and 161; group 1 at week 24 data points: 302 and 304; group 2 at week 24 data points: 203, 204, and 161. MR indicates mixed regression; OC, observed case.

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.8 FIGURE 3. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be FIGURE 3. Least squares mean change from baseline on the Mini-Mental State Examination at weeks 12 and 24 for donepezil and placebo (all patients) for OC, LOCF, and MR methods. Patients included in the OC and LOCF analyses at week 12 were from trials of at least 12 weeks in duration (ie, also included patients enrolled in trials 24 wk or longer). Patients included in the OC and LOCF analyses at week 24 had to have at least 24 weeks of treatment (ie, patients enrolled in 12-wk trials were excluded). For the MR, only patients enrolled in 12-week trials were included in week 12 analysis and only patients enrolled in 24-week (or more) trials were included in week 24 analysis. LOCF indicates last observation carried forward; MR, mixed regression; OC, observed case.

© 2009 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc.9 FIGURE 4. Rates of Cognitive Change in Alzheimer Disease: Observations Across a Decade of Placebo-controlled Clinical Trials With Donepezil. Jones, Roy; Schwam, Elias; Wilkinson, David; Waldemar, Gunhild; Feldman, Howard; Zhang, Richard; Albert, Kenneth; Schindler, Rachel Alzheimer Disease & Associated Disorders. 23(4): , October/December DOI: /WAD.0b013e31819cd4be FIGURE 4. Least squares mean change from baseline on the Alzheimer's Disease Assessment Scale-cognitive subscale at weeks 12 and 24 for donepezil and placebo (all patients) for OC, LOCF, and MR methods. Patients included in the OC and LOCF analyses at week 12 were from trials of at least 12 weeks in duration (ie, also included patients enrolled in 24-wk or longer trials). Patients included in the OC and LOCF analyses at week 24 had to have at least 24 weeks of treatment (ie, patients enrolled in 12-wk trials were excluded). For the MR, only patients enrolled in 12-week trials were included in week 12 analysis and only patients enrolled in 24-week (or more) trials were included in week 24 analysis. LOCF indicates last observation carried forward; MR, mixed regression; OC, observed case.