Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)

This study has been completed.

Study NCT00623103 Information provided by Novartis

First Received on February 14, 2008. Last Updated on October 19, 2011 History of Changes

Results First Received: October 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Parkinson's Disease Dementia
Interventions:	Drug: Rivastigmine capsule Drug: Rivastigmine transdermal patch

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 Capsule	Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
Rivastigmine Patch	Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.

Participant Flow: Overall Study

	Rivastigmine Capsule	Rivastigmine Patch
STARTED	295	288
Safety Set: Received Study Drug	294 ^[1]	288
COMPLETED	184	175
NOT COMPLETED	111	113
Adverse Event	70	60
Unsatisfactory therapeutic effect	4	12
Withdrawal by Subject	18	24
Lost to Follow-up	4	1
Administrative problems	2	4
Death	11	11
Protocol deviation	2	1

[1]	One randomized participant did not receive study drug and was not included in the Safety set.

Baseline Characteristics

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Reporting Groups

	Description
Rivastigmine Capsule	Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.
Rivastigmine Patch	Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm^2 patch or the highest well tolerated dose was maintained until week 76.

Baseline Measures

	Rivastigmine Capsule	Rivastigmine Patch	Total
Number of Participants [units: participants]	295	288	583
Age [units: years] Mean ± Standard Deviation	72.35 ± 6.295	72.26 ± 6.352	72.31 ± 6.318
Gender [units: participants]
Female	88	97	185
Male	207	191	398

Outcome Measures

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1. Primary:

Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) [ Time Frame: 76 Weeks ]

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2. Primary:

Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall) [ Time Frame: 76 Weeks ]

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3. Secondary:

Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline [ Time Frame: From Baseline to Weeks 8, 16, 24, 52 and 76 ]

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4. Secondary:

Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline [ Time Frame: From Baseline to Weeks 16, 24, 52 and 76 ]

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5. Secondary:

Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline [ Time Frame: From Baseline to Weeks 16, 24, 52 and 76 ]

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6. Secondary:

Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline [ Time Frame: At Week 16, 24, 52 and 76 (or early discontinuation) ]

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7. Secondary:

Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline [ Time Frame: From Baseline to Week 16, 24, 52 and 76 (or early discontinuation) ]

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8. Secondary:

UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation) [ Time Frame: From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation) ]

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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:	Novartis
ClinicalTrials.gov Identifier:	NCT00623103 History of Changes
Other Study ID Numbers:	CENA713B2315
Study First Received:	February 14, 2008
Results First Received:	October 19, 2011
Last Updated:	October 19, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Austria: Agency for Health and Food Safety; Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency