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 - ND

• Register: EUCTR
• Last refreshed on: 3 September 2012
• Main ID: EUCTR2007-000213-11-IT
• Date of registration: 14/01/2008
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: 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 - ND
• Scientific title: 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 - ND
• Date of first enrolment: 20/11/2007
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000213-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

France, Germany, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
Each patient will meet the following inclusion criteria at the time of the Baseline Visit (Visit 2): 1. 50-85 years of age; 2. males, and females not of child-bearing potential (surgically sterile or one year postmenopausal); 3. a diagnosis of dementia of the Alzheimer?s type according to the DSM-IV criteria; 4. a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria. The brain scan (magnetic resonance imaging (MRI) or computed tomography (CT)) used for establishing that these criteria are met must have been done within two years prior to the baseline visit; 5. an MMSE score of ≥ 10 and ≤ 24; 6. sufficient education to have been able to read, write, and communicate effectively during the premorbid state; 7. cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver; 8. residing with someone in the community throughout the study or, if living alone, in regular contact with the primary caregiver; 9. a primary caregiver willing to accept responsibility for supervising the treatment, (e.g., application and removal of the patch daily at approximately the same time of day) assessing the condition of the patient throughout the study, and for providing input to efficacy assessments in accordance with all protocol requirements; 10. patients who reside in an assisted living facility may be allowed to participate in the study provided the patient will be assessed at the study site and that a caregiver who meets the requirements of the protocol has been identified for the patient.
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:
Each patient will not meet any of the following exclusion criteria at the time of the Baseline Visit (Visit 2): 1. an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk; 2. any medical or neurological condition other than AD that could explain the patient?s dementia (e.g., abnormal thyroid function tests, Vitamin B12 or folate deficiency, posttraumatic conditions, Huntington?s disease, Parkinson?s disease, syphilis); 3. a current diagnosis of probable or possible vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association Internationale pour la Recherche et l?Enseignement en Neurosciences criteria (NINDS-AIREN); 4. a current DSM-IV diagnosis of major depression, unless successfully treated with a stable dose of an antidepressant without anticholinergic properties for at least 4 weeks; 5. any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient?s response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder; 6. a current diagnosis of active, uncontrolled seizure disorder; 7. a history within the past year or current diagnosis of cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms); 8. a current diagnosis of severe or unstable cardiovascular disease (e.g. unstable coronary artery disease, uncontrolled cardiac arrythmia); 9. a current diagnosis of bradycardia (< 50 bpm), sick-sinus syndrome, or conduction defects (sino-atrial block, second or third degree atrio-ventricular block); 10. a current diagnosis of acute, severe, or unstable asthmatic conditions [e.g., severe chronic obstructive pulmonary disease (COPD)]; 11. a current diagnosis of active, uncontrolled peptic ulceration or gastro-intestinal bleeding within the last 3 months; 12. clinically significant urinary obstruction; 13. 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; 14. current diagnosis of an active skin lesion/disorder that would prevent the patient from using a transdermal patch every day; 15. history of allergy to topical products containing vitamin E; 16. a disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty); 17. 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); 18. 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 st

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

Health Condition(s) or Problem(s) studied

Alzheimer's Disease
MedDRA version: 9.1 Level: LLT Classification code 10012271 Term: Dementia Alzheimer's type

Intervention(s)

Product Name: Exelon Patch
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rivastigmine
CAS Number: 123441-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 27-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Cutaneous use

Product Name: Exelon Patch
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rivastigmine
CAS Number: 123441-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 18-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Product Name: Exelon Patch
Product Code: ENA713
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: rivastigmine
CAS Number: 123441-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use

Primary Outcome(s)

Primary end point(s): The primary objective of this study is 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 doubleblind randomization baseline to Week 48 of the Double-blind Treatment Phase in cognition as assessed by the total ADAS-Cog score.

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 ADASCog score.

Secondary Objective: 1. 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 over the 48-Week Double-blind Treatment Phase in instrumental activities of daily living as assessed by the ADCSADL instrumental activities subscale; the time to functional decline (i.e. interval between double-blind randomization baseline to first decline from double-blind randomization baseline) in instrumental activities of daily living as assessed by the ADCS-ADL instrumental activities subscale over the 48-Week Double-blind Treatment Phase; the change from double-blind randomization baseline to Week 48 of the Double-blind Treatment Phase in attention and executive function as assessed by the Trail Making Test Parts A and B; pls see protocol

Secondary ID(s)

2007-000213-11-FR

CENA713D2340