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

Completed · Phase 4 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

Key facts

Study ID

NCT00948766

Run by

Novartis

People needed

716

Starts

2009-07-01

Expected to finish

2012-06-01

Last updated by the study team

2013-08-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwest Neuro Specialist, PLLC — Tucson, Arizona, United States
• IHS Research Center Inc. — Conway, Arkansas, United States
• East Bay Physicians Medical Group — Berkeley, California, United States
• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• Neuro Pain Medical Center — Fresno, California, United States
• Margolin Brain Institute — Fresno, California, United States
• Collaborative Neuroscience Network Inc. — Garden Grove, California, United States
• PCND Neuroscience Research Institute Inc./The Center for Memory and Aging — Poway, California, United States
• Anderson Clinical Research — Redlands, California, United States
• San Francisco Clinical Research Center — San Francisco, California, United States
• Neuropsychiatric Research Center of Orange County — Santa Ana, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Viking Clinical Research Center — Temecula, California, United States
• Collaborative Neuroscience Network, Inc — Torrance, California, United States
• Senior Care of Colorado — Aurora, Colorado, United States
• Clinical Research Studies Dept. of Clinical Science and Medical Education — Boca Raton, Florida, United States
• Quantum Laboratories Memory Disorder Center — Deerfield Beach, Florida, United States
• Brain Matters Research, Inc. — Delray Beach, Florida, United States
• Neurologic Consultants, PA — Fort Lauderdale, Florida, United States
• White-Wilson Medical Center — Fort Walton Beach, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Sunrise Clinical Research, Inc — Hollywood, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Integrity Research, LLC — Pensacola, Florida, United States
• Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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