Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Immediate Switch	Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
Delayed Switch	Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.

Participant Flow for 2 periods

Period 1:   Core Phase

	Immediate Switch	Delayed Switch
STARTED	131	131
Intent-to-treat Population	131	130 [1]
COMPLETED	120	120
NOT COMPLETED	11	11
Adverse Event	6	4
Lack of Efficacy	2	0
Abnormal test procedure result(s)	0	1
Withdrawal by Subject	3	4
Protocol deviation	0	2

Period 2:   Extension Phase

	Immediate Switch	Delayed Switch
STARTED	117 [1]	117
COMPLETED	85	91
NOT COMPLETED	32	26
Adverse Event	17	11
Lack of Efficacy	4	3
Withdrawal by Subject	6	6
Lost to Follow-up	0	3
Death	1	0
Protocol Violation	3	2
Administrative problems	1	1

Reporting Groups

	Description
Immediate Switch	Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
Delayed Switch	Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.

Baseline Measures

	Immediate Switch	Delayed Switch	Total
Number of Participants   [units: participants]	131	130	261
Age [1] [units: years] Mean ± Standard Deviation	77.8  ± 7.66	76.7  ± 8.41	77.3  ± 8.04
Gender   [units: participants]
Female	79	72	151
Male	52	58	110

1.  Primary:

Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study   [ Time Frame: Baseline through the end of the core phase of the study (Week 5) ]

2.  Secondary:

Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study   [ Time Frame: Baseline through the end of study (25 weeks) ]

3.  Secondary:

Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase   [ Time Frame: From week 5 through the end of extension phase (25 weeks) ]

4.  Secondary:

Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25   [ Time Frame: Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase) ]

5.  Secondary:

Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study   [ Time Frame: Baseline and Week 25 (end of the extension phase) and at the end of study ]

6.  Secondary:

Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study.   [ Time Frame: Baseline, Week 25 (end of the extension phase) and at End of Study ]

7.  Secondary:

Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study   [ Time Frame: Baseline, Week 25 (end of the extension phase) and at the end of Study ]