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A 24 Week Open-Label Extension to Study CENA713DUS44

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01054755
First received: January 21, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will obtain additional safety and efficacy data, as well as provide the higher dose rivastigmine patch to all patients who complete the double-blind phase in its entirety.


Condition Intervention Phase
Alzheimer's Disease
 Drug: ENA713
Drug: Rivastigmine transdermal patch 15 cm2
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 24 Week Open-Label Extension to Study CENA713DUS44: 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Obtain additional safety data. Physical Exam (including neurological exam), vital signs, weight, laboratory evaluations, electrocardiogram, Adverse events (SAE's, deaths) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in activities of daily living. Alzheimer's Disease Cooperative Study - Activities of Daily Living - Severe Impairment Version (ADCS-ADL-SIV) [ Time Frame: 4 weeks, 12 weeks & 24 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Change in cognitive function. Severity Impairment Battery (SIB) [ Time Frame: 4 weeks, 12 weeks & 24 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Clinician's rating of change. Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 4 weeks, 12 weeks & 24 weeks after start of treatment ] [ Designated as safety issue: No ]

Enrollment: 397
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rivastigmine 15 cm2 patch Drug: ENA713 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:

  • Complete the double-blind phase (Week 24) of the original protocol
  • Provide, if mentally competent, a separate written informed consent prior to their participation in the open-label extension. In addition, the patient's caregiver, will provide written informed consent prior to the patient's participation in the open-label extension. If the patient is not able to provide written informed consent, written informed consent must be obtained from the legally authorized representative on patient's behalf
  • Continue to reside with someone in the community or in regular contact with the primary caregiver; patients who reside in an assisted living facility are eligible to participate
  • Continue to have a primary caregiver willing to accept responsibility for supervising treatment (e.g., application and removal of the patch daily at approximately the same time of day), assessing the condition of the patient throughout the open-label extension
  • Must be medically stable and tolerating the current dose of rivastigmine patch as determined by the investigator

Exclusion Criteria:

  • Refer to the double-blind study protocol (CENA713DUS44) for full details of the exclusion criteria
  • Patients who discontinued the double-blind study due to any reason are excluded
  • No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054755

  Show 108 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01054755     History of Changes
Other Study ID Numbers: CENA713DUS44E1
Study First Received: January 21, 2010
Last Updated: January 15, 2013
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 May 22, 2013