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This study used two doses of rivastigmine transdermal patch (5 cm^2, 10 cm^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) | Experimental |
| |
| Rivastigmine patch (9.5 mg/day) | Experimental |
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| Rivastigmine capsules (6 mg to 12 mg/day) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine patch (4.6 mg/day switch to 9.5 mg/day) | Drug | Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study | Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). | Baseline to end of study (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only) | Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). |
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Inclusion Criteria:
Exclusion Criteria:
A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
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 vitamin E
Taken any of the following substances prior to randomization:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals, MD | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Barcelona | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day) | Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). |
| FG001 | Rivastigmine Patch (9.5 mg/Day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized |
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| Rivastigmine patch (9.5 mg/day) | Drug | Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). |
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| Rivastigmine capsules (6 mg to 12 mg/day) | Drug | Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment. |
|
| Baseline to end of study (Month 3) |
| Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study. | Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken. | Baseline to end of study (Month 3) |
| Overall Caregiver Satisfaction With Treatment | Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction. | At end of study (Month 3) |
| Overall Patient Satisfaction With Treatment | Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction. | At end of study (Month 3) |
| Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3 | The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | Baseline to Month 1 and Month 3 |
Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). |
| FG002 | Rivastigmine Capsules (6 mg to 12 mg/Day) | Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment. |
| COMPLETED |
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| NOT COMPLETED |
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| Received Study Drug |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day) | Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). |
| BG001 | Rivastigmine Patch (9.5 mg/Day) | Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). |
| BG002 | Rivastigmine Capsules (6 mg to 12 mg/Day) | Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment. |
| BG003 | Total | Total of all reporting groups |
| 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 | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 Had a Gastrointestinal Adverse Event (AE) at Any Time During the Study | Gastrointestinal adverse events (including nausea, vomiting, and diarrhea) were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). | The Safety population included all randomized patients who received at least one dose of the study medication. | Posted | Number | Percentage of participants | Baseline to end of study (Month 3) |
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| Secondary | Percentage of Patients With an AE Involving the Skin (Local Tolerance) Recorded Over the Course of the Study Period (Patch Groups Only) | Adverse events involving the skin included urticaria, pruritus, erythema, and pigmentation disorder. Only the groups administered rivastigmine transdermally via patch were analyzed. The adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). | The Safety population included all randomized patients who received at least one dose of the study medication. | Posted | Number | Percentage of participants | Baseline to end of study (Month 3) |
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| Secondary | Percentage of Patients With at Least 1 AE of Any Kind Recorded During the Period of the Study. | Adverse events were coded using the medical dictionary MedDRA v11.0 and the number of patients who suffered an AE were described by system organ class (SOC) and preferred term (PT). They were also tabulated by severity, relationship with study treatment, and action taken. | The Safety population included all randomized patients who received at least one dose of the study medication. | Posted | Number | Percentage of participants | Baseline to end of study (Month 3) |
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| Secondary | Overall Caregiver Satisfaction With Treatment | Caregivers were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction. | The Safety population included all randomized patients who received at least one dose of the study medication. | Posted | Number | Participants | At end of study (Month 3) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Patient Satisfaction With Treatment | Patients were asked to rate their overall degree of satisfaction with the Alzheimer's disease treatment on a scale of 1 to 5 (1 "Very good" - 5 "Very poor") at the end of the study (Month 3). A higher score indicates less satisfaction. | The Safety population included all randomized patients who received at least one dose of the study medication. | Posted | Number | Participants | At end of study (Month 3) |
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| Secondary | Change in the Total Mini-Mental State Examination (MMSE) Score From Baseline to Month 1 and Month 3 | The Mini Mental State Examination (MMSE) was used to evaluate the patient's cognitive status and how it progressed over time. The 35-point version used in this study was made up of five sections: orientation, fixation, attention and calculation, memory and language, and constructional praxis. The total score for each patient was obtained by adding the score from each of the above sections. The individual receives 1 point for each correct answer. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement. | The Safety population was made up of all the randomized patients who had taken at least one dose of the study medication. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Month 1 and Month 3 |
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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 Patch (4.6 mg/Day Switch to 9.5 mg/Day) | Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months). | 2 | 43 | 8 | 43 | ||
| EG001 | Rivastigmine Patch (9.5 mg/Day) | Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment). | 3 | 47 | 7 | 47 | ||
| EG002 | Rivastigmine Capsules (6 mg to 12 mg/Day) | Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment. | 1 | 49 | 8 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| Cerebellar haematoma | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 13.1 | 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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| Lost to Follow-up |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Male |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Rivastigmine Capsules (6 mg to 12 mg/Day) |
Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment. |
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