probable Alzheimer's disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: Exelon
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rivastigmine
CAS Number: 123441-03-2
Current Sponsor code: ENA713
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males, and females not of child-bearing potential (surgically sterile or at least one year postmenopausal) of at least 50 years of age; • Patients with probable Alzheimer’s disease according to the NINCDS-ADRDA and DSMIV criteria; • Patients having an MMSE score of > 10 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients not treated according to the product monograph for Exelon capsules; • Patients involved in a clinical trial; • Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application). • History of allergy to topical products containing any of the constituents of the patches. • History or presence of any contraindication for the application of the study drug as listed in the current Investigator’s Brochure, i.e. severe liver insufficiency, pancreatitis, gastric ulcer, sick-sinus-syndrome, disturbance of impulse transmission, asthma or other obstructive lung disease, convulsions, urinary retention. • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To support the clinical effectiveness of Exelon® target patch size 10 cm² by determining in a real life setting the percentage of patients who stay on the Exelon® target patch size of 10 cm² for at least 8 weeks. This proportion will then be compared to historic data with the percentage of patients who could reach Exelon® capsule target dose of 12 mg and stay on it at least 8 weeks, in previous Exelon trials.;Secondary Objective: To assess the cognitive and global outcome of the patients Brief global cognitive testing (MMSE) Clinical Global Impression of Change by the physician (ADCS-CGIC) Executive function (Trail Making test A) Instrumental Activities of Daily living (ADCS-ADL) To obtain safety/tolerability data (AEs and SAEs) To assess patient compliance with the patch (drug accounting) To assess caregiver preference and satisfaction with the patch (ADCPQ) To assess the caregiver burden (mini-Zarit score) To assess efficacy on 5cm² after 4 weeks of treatment, for all patients ;Primary end point(s): The primary endpoint is the proportion of patients treated by Exelon® 10 cm² patch sizes for at least 8 weeks at week 24. | — |
Countries
Germany
Outcome results
None listed