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A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease (BETTER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01047579
First Posted: January 13, 2010
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.

Condition Intervention Phase
Alzheimer's Disease Drug: Rivastigmine transdermal Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Caregiver questionnaire [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Safety and Tolerability. Safety assessments include vital signs and adverse events (AEs) [ Time Frame: every visit ]

Enrollment: 51
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rivastigmine transdermal Drug: Rivastigmine transdermal

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
  • MMSE score of >10 and <26.
  • Patients who were under ChE inhibitor treatment and experienced adverse events.
  • Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.

Exclusion Criteria:

  • Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
  • Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
  • History of allergy to topical products containing any of the constitution of the patches.
  • Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
  • Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
  • Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047579


Locations
Israel
Novartis Investigative Site
Ashkelon, Israel
Novartis Investigational Site
Haifa, Israel
Novartis Investigative Site
Holon, Israel
Novartis Investigative Site
Ramat Gan, Israel
Novartis Investigative Site
Tel Aviv, Israel
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01047579     History of Changes
Other Study ID Numbers: CENA713DIL01
First Submitted: January 12, 2010
First Posted: January 13, 2010
Last Update Posted: February 24, 2017
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Alzheimer's Disease
Rivastigmine transdermal
caregiver preference

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents