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)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-001383-70-DE
• Date of registration: 13/06/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 26/09/2007
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001383-70
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion 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 < 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
o patients who have experienced a tolerability issue with other ChEI or who are at high risk of drug-drug interactions,
o patients 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,
o patients 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

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

probable Alzheimer's disease
MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease

Intervention(s)

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 type: equal
Concentration number: 9-

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 type: equal
Concentration number: 18-

Primary Outcome(s)

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.

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

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 ID(s)

CENA713DDE15