Alzheimer’s disease dementia MedDRA version: 9.1 Level: LLT Classification code 10012271 Term: Dementia Alzheimer's type
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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). 5. Patients who reside in an assisted living facility may be allowed to participate provided the patient will be assessed at the study site and a caregiver has been identified. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of target Exelon® 10 cm2 patch vs. target Exelon® 15 cm2 patch in patients who have demonstrated cognitive decline in the initial Open-label Treatment Phase (Exelon® 10 cm2 patch) with respect to the change from double-blind randomization baseline to Week 48 of the Double-blind Treatment Phase in cognition as assessed by the total ADAS-Cog score.;Secondary Objective: • To compare the efficacy of target Exelon® 10 cm2 patch vs. target Exelon® 15 cm2 patch in patients who have demonstrated cognitive decline in the initial Open-label Treatment Phase (Exelon® 10 cm2 patch) with respect to the change from double-blind randomization baseline to Week 48 of the Double-blind Treatment Phase and the time to decline over the 48-Week Double-blind Treatment Phase in instrumental activities of daily living as assessed by the ADCS-ADL instrumental activities subscale; • To compare the safety and tolerability of target Exelon® 10 cm2 patch vs. target Exelon® 15 cm2 patch. ;Primary end point(s): Primary efficacy parameter: Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Secondary efficacy assessment parameters: • Alzheimer’s Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-Instrumental ADL) • Trail Making Test Part A & B • 10-item Neuropsychiatric Inventory (NPI-10). | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed