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| ID | Type | Description | Link |
|---|---|---|---|
| CENA713DUS38E1 | Other Identifier | Novartis |
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This study was designed to evaluate the safety and tolerability of switching from donepezil to an initial dose of 5cm^2 rivastigmine patch formulation in patients with probable Alzheimer's Disease (MMSE 10-24). The study included a 5-week, open-label, randomized period followed by a 20-week open-label extension period. Patients were randomized to either an immediate switch from donepezil to rivastigmine patch formulation or to a switch to rivastigmine patch formulation following a 7-day withdrawal period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Switch | Experimental | Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
| Delayed Switch | Experimental | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine 5 cm^2 transdermal patch | Drug | Rivastigmine 5 cm^2 patch size, loaded with 9 mg and providing 4.6 mg rivastigmine per 24 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study | The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase. | Baseline through the end of the core phase of the study (Week 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study | A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dedicated Clinical Research | Sun City | Arizona | 85351 | United States | ||
| ATP Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19929593 | Derived | Farlow MR, Alva G, Meng X, Olin JT. A 25-week, open-label trial investigating rivastigmine transdermal patches with concomitant memantine in mild-to-moderate Alzheimer's disease: a post hoc analysis. Curr Med Res Opin. 2010 Feb;26(2):263-9. doi: 10.1185/03007990903434914. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Switch | Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Core Phase |
|
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| Rivastigmine 10 cm^2 transdermal patch | Drug | Rivastigmine 10 cm^2 patch size loaded with 18 mg and providing 9.5 mg rivastigmine per 24 hours. |
|
| Baseline through the end of study (25 weeks) |
| Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase | A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study. | From week 5 through the end of extension phase (25 weeks) |
| Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25 | The CGIC is an assessment tool used by a skilled 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 clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) "very much improved" to (4) "no change" to (7) "very much worse". | Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase) |
| Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study | 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. | Baseline and Week 25 (end of the extension phase) and at the end of study |
| Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study. | The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement. | Baseline, Week 25 (end of the extension phase) and at End of Study |
| Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study | The ADCS-ADL scale is composed of 23 items to assess the 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, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement. | Baseline, Week 25 (end of the extension phase) and at the end of Study |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Margolin Brain Institute | Fresno | California | 93720 | United States |
| Investigative site | Denver | Colorado | 80209 | United States |
| Berma Research Group | Hialeah | Florida | 33016 | United States |
| Sunrise Clinical Research | Hollywood | Florida | 33021 | United States |
| Center for Clinical Trials | Venice | Florida | 34285 | United States |
| Premiere Research Institute @ Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Medical Associates of North Georgia | Canton | Georgia | 30114 | United States |
| Medical Associates of North Georgia | Cumming | Georgia | 30040 | United States |
| Witham Health Services | Lebanon | Indiana | 46052 | United States |
| Investigative site | Pittsfield | Massachusetts | 01201 | United States |
| Rochester Center For Behavioral Medicine | Rochester Hills | Michigan | 48307 | United States |
| Alzheimer's Research Corporation | Manchester | New Hampshire | 08759 | United States |
| Investigative site | Long Branch | New Jersey | 07740 | United States |
| Neurobehavioral Research, Inc | Cedarhurst | New York | 11516 | United States |
| Eastside Comprehensive Medical Center | New York | New York | 10021 | United States |
| Investigative site | Centerville | Ohio | 45459 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Investigative site | Eugene | Oregon | 97401 | United States |
| The Clinical Trial Center | Jenkintown | Pennsylvania | 19046 | United States |
| Senior Adults Specialty Research | Austin | Texas | 78757 | United States |
| Investigative site | Bennington | Vermont | 05201 | United States |
| FG001 | Delayed Switch | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
| Intent-to-treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Switch | Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
| BG001 | Delayed Switch | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data is provided for the Intent-to-treat / Safety population. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants Who Discontinued From the Study Due to Any Reason During the Core Phase of the Study | The primary objective of the study was to evaluate the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD). The primary variable to assess tolerability of switching was the number of participants who discontinued from the study due to any reason during the core phase. | The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received. | Posted | Number | Participants | Baseline through the end of the core phase of the study (Week 5) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued From the Study Due to Any Adverse Event (AE) During the Combined Core and Extension Phases of the Study | A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to an AE during the combined core and extension phases of the study. | The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received. | Posted | Number | Participants | Baseline through the end of study (25 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Discontinued From Study Due to Any Reason During Extension Phase | A secondary assessment of the safety and tolerability of 2 paradigms for switching from donepezil to rivastigmine patch in patients with Alzheimer's disease (AD) was the number of participants who discontinued from the study due to any reason during extension phases of the study. | The Safety population consisted of all randomized patients who had at least 1 post-baseline safety assessment. Patients were analyzed according to the treatment received. | Posted | Number | Participants | From week 5 through the end of extension phase (25 weeks) |
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Clinical Global Impression of Change (CGIC) Score at Week 5 and Week 25 | The CGIC is an assessment tool used by a skilled 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 clinician does not have access to any post-baseline cognitive testing data. The CGIC is rated on a seven-point scale, ranging from (1) "very much improved" to (4) "no change" to (7) "very much worse". | The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 5 (end of the core phase) and Week 25 (end of the extension phase) |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Mini Mental State Exam (MMSE) Score at Week 25 and at the End of Study | 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 included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 25 (end of the extension phase) and at the end of study |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Neuropsychiatric Inventory - 10 Item (NPI-10) Score at Week 25 and at the End of Study. | The NPI-10 assesses a wide range of behavior problems encountered in dementia patients. The 10 behavioral domains comprising the NPI-10 are evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 10 domains yields the NPI total score, which ranges from 0 to 120, the lower the score the less severe the symptoms. A negative change score from baseline indicates improvement. | The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 25 (end of the extension phase) and at End of Study |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score at Week 25 and at the End of Study | The ADCS-ADL scale is composed of 23 items to assess the 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, making judgments and decisions. Responses for each item are obtained through a caregiver interview. The total score is the sum of all items and sub-questions. The range for the total ADCS-ADL score is 0 to 78; a higher score indicates a more self-sufficient individual. A positive change from baseline indicates improvement. | The Intent-to-Treat (ITT) population included all randomized patients who entered the switch period for at least 1 day and had at least 1 post-baseline assessment of tolerability/safety. This outcome used observed cases without imputation (OC). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 25 (end of the extension phase) and at the end of Study |
|
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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 | Immediate Switch | Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. | 14 | 131 | 51 | 131 | ||
| EG001 | Delayed Switch | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. | 9 | 130 | 51 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Oral intake reduced | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Benign vaginal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Application site reaction | General disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Death |
|
| Protocol Violation |
|
| Administrative problems |
|
| Male |
|
Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
|
Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
|
|
| OG001 | Delayed Switch | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
|
| Delayed Switch |
Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
|
| OG001 | Delayed Switch | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
|
| OG001 | Delayed Switch | Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study. |
|
|