A 24 week, multicenter, open evaluation of the clinical effectiveness of the once-daily 10 cm2 Exelon® patch formulation in patients with probable Alzheimer’s disease (MMSE10-26)
- Conditions
- probable Alzheimer's diseaseMedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's disease
- Registration Number
- EUCTR2007-001383-70-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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 < 26;
•Patients initiating therapy for the first time with a ChE inhibitor (patients prescribed both Exelon and memantine are allowed) OR Patients who failed to benefit from previous ChE inhibitor treatment
opatients who have experienced a tolerability issue with other ChEI or who are at high risk of drug-drug interactions,
opatients with cognitive, behavioral or functional worsening within the last 6 months under other ChEI or memantine treatment. The worsening should be confirmed by a decrease of at least 2 points within 1 year in the MMSE score,
opatients who don’t succeed to reach Exelon capsule 12 mg due to tolerability issue;
•Patients who are cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver;
•Patients residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday;
•Patients with a primary caregiver willing to accept responsibility for supervising the treatment (e.g., application and removal of the patch(es) daily at approximately the same time of day) and condition of the patient throughout the study and for providing input to efficacy assessments in accordance with all protocol requirement
•Written informed consent to participate in the trial from:
- the patient and his/her legal representative (if applicable)
- the primary caregiver
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method