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| ID | Type | Description | Link |
|---|---|---|---|
| N° EudraCT : 2007-003405-27 |
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This study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm^2 in patients with probable Alzheimer's Disease (Mini-Mental State Examination 10-26) in the community setting
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine transdermal patch | Drug | The study treatment was delivered as a patch sizes 5 and 10 cm^2 containing respectively 9 and 18 mg of rivastigmine. During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study | The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Change (CGI-C) by Physician | The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:"very much improved", "much improved", "slightly improved", "unchanged", "slightly worsened", "much worsened" and "very much worsened". |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma S.A.S. | Novartis Pharmaceuticals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Rueil-Malmaison | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine Transdermal Patch | During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline and week 24 |
| Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score | The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening. | Baseline to week 24 |
| Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline. | Baseline to week 24 |
| Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score | The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. | Baseline to week 24 |
| Exposed to Study Drug |
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| Intent to Treat (ITT) Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine Transdermal Patch | During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Baseline Measures are provided for the ITT population. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Achieved and Maintained the Maximum Dose of 10 cm^2 Rivastigmine Patch for at Least 8 Weeks During 24 Weeks Study | The primary endpoint was the percentage of patients who were able to tolerate (and stay on for at least 8 weeks) rivastigmine target patch size 10 cm^2. | The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. | Posted | Number | Percentage of participants | 24 weeks |
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| Secondary | Clinical Global Impression of Change (CGI-C) by Physician | The CGIC is an assessment tool used by a clinician to make a judgment of the severity or a change of a patient's condition. The clinician relies solely on information obtained from the patient at the Baseline visit as well as clinical information obtained throughout the study period. The CGIC is rated on the following seven-point scale:"very much improved", "much improved", "slightly improved", "unchanged", "slightly worsened", "much worsened" and "very much worsened". | The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. Last observation carried forward (LOCF) was used for missing values. | Posted | Number | Percentage of participants | Baseline and week 24 |
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| Secondary | Mean Change From Baseline to Week 24 in the 4-item Instrumental Activities of Daily Living (4-IADL) Score | The 4-IADL assesses the ability of a patient to autonomously perform 4 activities of daily living: Use the telephone, take medications, use public transport, and manage their own budget. Each activity is assessed by a series of questions and rated on a scale of 1 to 4. Scores on the 4 activities are combined for a total score ranging from 1 to 16. A lower score indicates a more self-sufficient individual. A positive change from baseline score indicates worsening. | The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to week 24 |
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| Secondary | Mean Change From Baseline to Week 24 in the Mini-Mental State Examination (MMSE) Score | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score from 0 to 30, with higher scores indicating better function. A positive change score indicates improvement from baseline. | The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to week 24 |
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| Secondary | Mean Change From Baseline to Week 24 in the Mini-Zarit Inventory Score | The Mini-Zarit Inventory assesses the burden of a caregiver in caring for a patient. The inventory is composed of 5 questions which are rated according to the following answers: 0 = never, ½ = sometimes, 1 = often. The ratings on the 5 questions are added together resulting in a total score of 0 to 7 with a higher score indicating greater caregiver burden. | The Intent-to-Treat (ITT) population was defined as all patients who were administered at least one dose of study medication and were assessed for efficacy at least 1 time. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to week 24 |
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Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rivastigmine Transdermal Patch | During the first 4 weeks of the study, patients applied a new rivastigmine 5 cm^2 patch once daily. At the end of the 4 weeks, if tolerability was satisfactory, the dosage was increased and patients applied rivastigmine 10 cm^2 patch once daily for an additional 4 weeks. Thereafter, and until the end of the study, patients remained at the maximum tolerated dose, either 5 or 10 cm^2. | 21 | 218 | 13 | 218 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA | Systematic Assessment |
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| BRADYCARDIA | Cardiac disorders | MedDRA | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | MedDRA | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| SIGMOIDITIS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| MALAISE | General disorders | MedDRA | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| HEPATOMEGALY | Hepatobiliary disorders | MedDRA | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| FOREARM FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| BIOPSY PROSTATE | Investigations | MedDRA | Systematic Assessment |
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| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| PROSTATIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| AUTONOMIC NERVOUS SYSTEM IMBALANCE | Nervous system disorders | MedDRA | Systematic Assessment |
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| DYSSTASIA | Nervous system disorders | MedDRA | Systematic Assessment |
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| EPILEPSY | Nervous system disorders | MedDRA | Systematic Assessment |
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| APATHY | Psychiatric disorders | MedDRA | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| SOCIAL STAY HOSPITALISATION | Social circumstances | MedDRA | Systematic Assessment |
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| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| MALIGNANT TUMOUR EXCISION | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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