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 - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00549601

Purpose

This study will use two doses of rivastigmine transdermal patch (5cm2, 10cm2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3mg/bid, 4,5mg/bid, 6mg/bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience and caregivers preferences of rivastigmine transdermal patch versus capsules.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: rivastigmine transdermal patch Drug: rivastigmine capsules	Phase IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Caregivers

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Feasibility of the Switch From Rivastigmine Capsules to Rivastigmine Transdermal Patch: Randomized, Open Label, Controlled Multicenter Study

Further study details as provided by Novartis:

Primary Outcome Measures:

The mean incidence of gastrointestinal adverse events between the two study groups. [ Time Frame: At all visits during the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The mean incidence of any adverse events between the two study groups. [ Time Frame: At all visits during the study ] [ Designated as safety issue: Yes ]
The mean incidence of skin adverse events between the two study groups. [ Time Frame: At all visits during the study ] [ Designated as safety issue: Yes ]
Caregiver / patient satisfaction with transdermal patch treatment. [ Time Frame: At last visit ] [ Designated as safety issue: No ]
Changes in Mini Mental State Examination (MMSE in both transdermal patch treatment groups. [ Time Frame: From baseline to visit 2 and last visit. ] [ Designated as safety issue: No ]

Estimated Enrollment:	144
Study Start Date:	November 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: rivastigmine transdermal patch
2: Experimental	Drug: rivastigmine transdermal patch
3: Active Comparator	Drug: rivastigmine capsules

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet DSM-IV (Diagnostic & Statistical Manual of Mental Disorders) criteria for dementia of Alzheimer Type and NINCDS-ADRDA(National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)criteria for probable AD, have a MMSE (Mini Mental State Examination)score > 10 and < 26
Have received continuous treatment with rivastigmine capsules at least with 3 mg / bid (6mg of total daily dose) for at least 3 moths before entering in the study
Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver
Have a primary caregiver willing to accept responsibility for supervising the treatment, (e.g., application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study.

Exclusion Criteria:

A medical or neurological condition other that AD that could explain the patients dementia (e.g. Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
History of allergy to topical products containing vitamin E
Taken any of the following substances prior to randomization:
- succinylcholine-type muscle relaxants during the previous 2 weeks
- an investigational drug during the previous 4 weeks

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549601

Contacts

Contact: Novartis Pharmaceuticals

+41 61 324 1111

Locations

Spain
Novartis Investigative Site	Recruiting
Barcelona, Spain

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals, MD

Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CENA713DES07
Study First Received:	October 24, 2007
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00549601
Health Authority:	Spain: Agencia Española del Medicamento

Keywords provided by Novartis:

Alzheimer's
rivastigmine
transdermal
safety

randomized
switch
patch

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Rivastigmine
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents

Protective Agents
Pharmacologic Actions
Cholinesterase Inhibitors
Therapeutic Uses
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009