Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type - NCT00948766-33613B (Clinical Trial 303863)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy303863.aspx
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| City: |
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Tampa |
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State:
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FL |
| Zip Code: |
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33613 |
| Conditions: |
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Alzheimer's Disease |
| Purpose: |
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This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared
to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the
Alzheimer's type.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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.
- an Mini Mental State Examination (MMSE) score of ≥ 3 and ≤ 12
- be able to complete at least one item on the SIB
- residing with someone in the community or in regular contact with the primary
caregiver
- be ambulatory or ambulatory with aid
Exclusion Criteria:
- 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 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 (e.g., tacrine, physostigmine, or pyridostigmine), 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.
Other protocol-defined inclusion/exclusion criteria may apply |
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| Study is available at: |
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Stedman Clinical Trials
Tampa, FL 33613
United States
Primary Contact:
Phone: 813-971-8311
Secondary Contact:
Novartis Pharmaceuticals
Phone: +1 862-778-8300 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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