Text Size

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

January 21, 2010
January 15, 2013
January 2010
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01054755 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A 24 Week Open-Label Extension to Study CENA713DUS44
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).

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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: ENA713
  • Drug: Rivastigmine transdermal patch 15 cm2
Experimental: Rivastigmine 15 cm2 patch
Interventions:
  • Drug: ENA713
  • Drug: Rivastigmine transdermal patch 15 cm2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
397
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01054755
CENA713DUS44E1
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP