Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease (KAPA)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00549601

First received: October 24, 2007

Last updated: February 24, 2011

Last verified: February 2011

History of Changes

Results First Received: January 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Alzheimer's Disease
Interventions:	Drug: Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) Drug: Rivastigmine patch (9.5 mg/day) Drug: Rivastigmine capsules (6 mg to 12 mg/day)

Participant Flow

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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
Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)	Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
Rivastigmine Patch (9.5 mg/Day)	Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
Rivastigmine Capsules (6 mg to 12 mg/Day)	Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.

Participant Flow for 2 periods

Period 1: Randomized

	Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)	Rivastigmine Patch (9.5 mg/Day)	Rivastigmine Capsules (6 mg to 12 mg/Day)
STARTED	43	48	51
COMPLETED	43	47	49
NOT COMPLETED	0	1	2
Protocol Violation	0	0	1
Withdrawal by Subject	0	1	1

Period 2: Received Study Drug

	Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)	Rivastigmine Patch (9.5 mg/Day)	Rivastigmine Capsules (6 mg to 12 mg/Day)
STARTED	43 ^[1]	47 ^[1]	49 ^[1]
COMPLETED	36	36	45
NOT COMPLETED	7	11	4
Adverse Event	2	5	1
Death	0	1	0
Lost to Follow-up	0	1	1
Protocol Violation	3	4	1
Withdrawal by Subject	2	0	1

[1]	Subjects who started this period (safety population) received at least 1 dose of study drug.

Baseline Characteristics

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Reporting Groups

	Description
Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)	Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
Rivastigmine Patch (9.5 mg/Day)	Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
Rivastigmine Capsules (6 mg to 12 mg/Day)	Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
Total	Total of all reporting groups

Baseline Measures

	Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)	Rivastigmine Patch (9.5 mg/Day)	Rivastigmine Capsules (6 mg to 12 mg/Day)	Total
Number of Participants [units: participants]	43	47	49	139
Age [units: years] Mean ± Standard Deviation	77.05 ± 4.82	75.34 ± 7.25	77.35 ± 6.62	76.58 ± 6.37
Gender [units: participants]
Female	30	29	25	84
Male	13	18	24	55

Outcome Measures

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1. Primary:

Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study [ Time Frame: Baseline to end of study (Month 3) ]

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2. Secondary:

Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only) [ Time Frame: Baseline to end of study (Month 3) ]

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3. Secondary:

Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study. [ Time Frame: Baseline to end of study (Month 3) ]

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4. Secondary:

Overall Caregiver Satisfaction With Treatment [ Time Frame: At end of study (Month 3) ]

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5. Secondary:

Overall Patient Satisfaction With Treatment [ Time Frame: At end of study (Month 3) ]

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6. Secondary:

Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3 [ Time Frame: Baseline to Month 1 and Month 3 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00549601 History of Changes
Other Study ID Numbers:	CENA713DES07
Study First Received:	October 24, 2007
Results First Received:	January 5, 2011
Last Updated:	February 24, 2011
Health Authority:	Spain: Agencia Española del Medicamento

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