Status:
COMPLETED
Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44
Lead Sponsor:
Novartis
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\^2 patch)...
Eligibility Criteria
Inclusion
- Core study
- 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.
- A Mini-Mental State Examination (MMSE) score of ≥ 3 and ≤ 12.
- Be able to complete at least 1 item on the Severe Impairment Battery (SIB).
- Residing with someone in the community or in regular contact with the primary caregiver.
- Be ambulatory or ambulatory with aid.
Exclusion
- 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 beats per minute \[bpm\]), 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 (eg, tacrine, physostigmine, or pyridostigmine), or 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.
- Extension study
- Inclusion Criteria:
- Complete the double-blind phase (Week 24) of the core study.
- Provide, if mentally competent, a separate written informed consent prior to participation in the extension study. In addition, the patient's caregiver, will provide written informed consent prior to the patient's participation in the open-label extension study. If the patient is not able to provide written informed consent, written informed consent must be obtained from the legally authorized representative on the 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 (eg, application and removal of the patch daily at approximately the same time of day), assessing the condition of the patient throughout the extension study.
- Must be medically stable and tolerating the current dose of rivastigmine patch as determined by the investigator.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
716 Patients enrolled
Trial Details
Trial ID
NCT00948766
Start Date
July 1 2009
End Date
June 1 2012
Last Update
August 28 2013
Active Locations (95)
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1
Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc
Tempe, Arizona, United States, 85282
2
Northwest Neuro Specialist, PLLC
Tucson, Arizona, United States, 86741
3
IHS Research Center Inc.
Conway, Arkansas, United States, 72034
4
East Bay Physicians Medical Group
Berkeley, California, United States, 94705