EUCTR2007-000213-11-DEActive, not recruitingNot Applicable
A 48-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Evaluation of the Comparative Efficacy, Safety, and Tolerability of Exelon® 10 and 15 cm2 Patch in Patients with Alzheimer’s Disease Showing Cognitive Decline during an Initial Open-Label Treatment Phase.
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 1,200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or female patients between 50 and 85 years of age with a diagnosis of dementia of the Alzheimer’s type according to the DSM IV criteria in addition to a clinical diagnosis of probable Alzheimer’s Disease (AD) according to the NINCDS/ADRDA criteria.
- •2. Patients with a baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive.
- •3. Each patient will be required to have a primary caregiver willing to accept responsibility for supervising treatment, assessing the patient’s condition throughout the study, and for providing input into efficacy assessments.
- •4. Females not of child-bearing potential (surgically sterile or one year postmenopausal).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Presence of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments or put the patient at particular risk.
- •2. Any medical or neurological condition other than AD that could explain the patient’s dementia, a diagnosis of probable or possible vascular dementia.
- •3. A current DSM-IV diagnosis of unsuccessfully-treated major depression, or any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient’s response to study medication.
- •4. A current diagnosis of active, uncontrolled seizure disorder;
- •5. A history within the past year or current diagnosis of cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms);
- •6. A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease, uncontrolled cardiac arrythmia);
- •7. A current diagnosis of bradycardia (< 50 bpm), sick-sinus syndrome, or conduction defects (sino-atrial block, second or third degree atrio-ventricular block);
- •8. A current diagnosis of acute, severe, or unstable asthmatic conditions [e.g., severe chronic obstructive pulmonary disease (COPD)];
- •9. A current diagnosis of active, uncontrolled peptic ulceration or gastro-intestinal bleeding within the last 3 months;
- •10. Clinically significant urinary obstruction;
- •11. 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;
- •12. Current diagnosis of an active skin lesion/disorder that would prevent the patient from using a transdermal patch every day;
- •13. History of allergy to topical products containing vitamin E;
- •14. A disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty);
- •15. A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine, or to other cholinergic compounds (e.g., pilocarpine, bethanechol, tacrine, donepezil, velnacrine, metrifonate, galantamine, or physostigmine);
- •16. Patients taken any of the following substances prior to receiving study treatment:
- •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;
- •any new psychotropic medication or dopaminergic agent or any psychotropic medication or dopaminergic agent not taken at a stable dose 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.
Investigators
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