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This study evaluated the safety and efficacy of 10 cm^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine 5 and 10 cm^2 patch | Experimental | For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine 5 and 10 cm^2 patch | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study | Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver. | Baseline to Week 24 |
| Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study | Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver. | Baseline to Week 24 |
| Percentage of Participants Who Were Compliant to the 10 cm^2 Patch | Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24 | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Munich | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21645184 | Derived | Articus K, Baier M, Tracik F, Kuhn F, Preuss UW, Kurz A. A 24-week, multicentre, open evaluation of the clinical effectiveness of the rivastigmine patch in patients with probable Alzheimer's disease. Int J Clin Pract. 2011 Jul;65(7):790-6. doi: 10.1111/j.1742-1241.2011.02713.x. Epub 2011 Jun 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine 5 and 10 cm^2 Patch | For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine 5 and 10 cm^2 Patch | For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Who Completed the Study | Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
|
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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 5 and 10 cm^2 Patch | For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline and Week 24 |
| Mean Change From Baseline in the Trail-making Test Part A Score at Week 24 | The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement. | Baseline to Week 24 |
| Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24 | The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement. | Baseline to Week 24 |
| Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician | The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category. | Baseline to Week 24 |
| Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver | The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. | Baseline t0 Week 24 |
| Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24 | 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. A negative change score indicates reduced burden. | Baseline to Week 24 |
| Withdrawal by Subject |
|
| Administrative problems |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 24 | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in the Trail-making Test Part A Score at Week 24 | The Trail-making test is a neuropsychological test of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive numbers (1,2,3, etc.) on a sheet of paper or computer screen. The goal of the subject is to finish the test as quickly as possible, and the time taken to complete the test is used as the primary performance metric (in seconds). The maximum time allowed is 300 seconds. A negative change score indicates improvement. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Mean | Standard Deviation | Seconds | Baseline to Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score at Week 24 | The ADCS-ADL scale is composed of 23 items developed to assess a patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item will be obtained from the caregiver through an interview. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change score indicates improvement. | 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 | Units on a scale | Baseline to Week 24 |
|
|
|
| Secondary | Change From Baseline in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Physician | The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. Results are reported as number of patients in the indicated change category. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Number | Participants | Baseline to Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in the Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC) at Week 24 Assessed by the Caregiver | The ADCS-CGIC is an assessment tool to make a judgment of change in a patient's condition. Change is derived from comparing an assessment performed at baseline versus an assessment at the end of the study. Change is categorized into 1 of 7 categories: No change; minimal, moderate, or marked improvement; or minimal, moderate, or marked decline. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Number | Participants | Baseline t0 Week 24 |
|
|
|
| Primary | Percentage of Participants Treated by Rivastigmine 10 cm^2 Patch for at Least 8 Weeks Regardless Whether They Completed the Study | Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Week 24 |
|
|
|
| Primary | Percentage of Participants Who Were Compliant to the 10 cm^2 Patch | Dosages of study medication prescribed to and taken by the patient was assessed in a "Drug Administration Record" with start date, end date, dosage and reason for dose adjustment (if applicable). Data was amended by counting the returned medication at the study visits and information by the caregiver. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Mean | Standard Deviation | Percentage of participants | Baseline to Week 24 |
|
|
|
| Secondary | Mean Change From Baseline in the Mini-Zarit Inventory Score of Caregiver Burden at Week 24 | 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. A negative change score indicates reduced burden. | The Intent-to-Treat (ITT) population was defined as all randomized patients who were administered at least one dose of study medication and were assessed at baseline and post-baseline for efficacy at least 1 time. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 24 |
|
|
|
| 18 |
| 208 |
| 49 |
| 208 |
| Death | General disorders | 12.1 | Systematic Assessment |
|
| Fatigue | General disorders | 12.1 | Systematic Assessment |
|
| Malaise | General disorders | 12.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | 12.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | 12.1 | Systematic Assessment |
|
| Blood glucose abnormal | Investigations | 12.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | 12.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | 12.1 | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 12.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | 12.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | 12.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | 12.1 | Systematic Assessment |
|
| Dysstasis | Nervous system disorders | 12.1 | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | 12.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | 12.1 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | 12.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | 12.1 | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | 12.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | 12.1 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | 12.1 | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | 12.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | 12.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | 12.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 12.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | 12.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 12.1 | Systematic Assessment |
|
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.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Marked improvement |
|
| Minimal decline |
|
| Moderate decline |
|
| Marked decline |
|
| Title | Measurements |
|---|---|
|
| Marked improvement |
|
| Minimal decline |
|
| Moderate decline |
|
| Marked decline |
|