Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00948766

Purpose

This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzheimer's type.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: rivastigmine transdermal patch 15 cm2 Drug: rivastigmine transdermal patch 5 cm2	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 24 Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of Rivastigmine Patch 15 cm2 vs. Rivastigmine Patch 5 cm2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION).

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Rivastigmine SDZ-ENA 713

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in activities of daily living assessed using the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV). Change in cognition assessed using the Severe Impairment Battery (SIB) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in behavior assessed using the Neuropsychiatric Inventory (NPI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change in global functioning assessed using the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Assess the safety and tolerability of the 15 cm2 rivastigmine patch. Safety assessments will include a physical exam, height/weight, vital signs, laboratory evaluations, electrocardiograms (ECG), skin irritation and adverse events (AEs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	712
Study Start Date:	July 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: rivastigmine 5 cm2 patch	Drug: rivastigmine transdermal patch 5 cm2
Experimental: rivastigmine 15 cm2 patch	Drug: rivastigmine transdermal patch 15 cm2

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of probable Alzheimer's disease (AD) according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
an Mini Mental State Examination (MMSE) score of ≥ 3 and ≤ 12
be able to complete at least one item on the SIB
residing with someone in the community or in regular contact with the primary caregiver
be ambulatory or ambulatory with aid

Exclusion Criteria:

an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk
patients currently residing in a nursing home
any current medical or neurological condition other than AD that could explain the patient's dementia
a current diagnosis of probable or possible vascular dementia
a current diagnosis of severe or unstable cardiovascular disease
a current diagnosis of bradycardia (< 50 bpm), sick-sinus syndrome, or conduction defects
clinically significant urinary obstruction
history of malignancy of any organ system within the past 5 years unless patient is verified to be in stable condition with no active metastasis
current diagnosis of an active skin lesion/disorder that would prevent the patient from using a transdermal patch every day
a known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine, or to other cholinergic compounds
taken any of the following substances (At the time of the Baseline Visit (Visit 2))
succinylcholine-type muscle relaxants during the previous 2 weeks;
lithium during the previous 2 weeks;
an investigational drug during the previous 4 weeks;
a drug or treatment known to cause major organ system toxicity during the previous 4 weeks;
rivastigmine (oral or transdermal patch), donepezil, galantamine, other cholinesterase inhibitors (e.g., tacrine, physostigmine, or pyridostigmine), other approved treatments for Alzheimer's disease during the previous 2 weeks with exception of stable treatment with memantine for at least 3 months before study entry (Visit 1)
centrally acting anticholinergic drugs including tricyclic and tetracyclic antidepressants during the previous 4 weeks;
selegiline unless taken at a stable dose during the previous 4 weeks;
peripheral anticholinergics not taken at a stable dose 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: NCT00948766

Show 92 Study Locations

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Online Screening Questionnaire is available This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00948766 History of Changes
Other Study ID Numbers:	CENA713DUS44
Study First Received:	July 28, 2009
Last Updated:	November 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Alzheimer's disease
dementia
Alzheimer's type

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012