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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 step | Experimental |
| |
| 3 step | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator | Drug | 1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation | The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) | The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline. | Baseline, 8,16, and 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anjo | Aichi-ken | 446-8510 | Japan | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine Patch 1 Step | 1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day |
| FG001 | Rivastigmine Patch 3 Step |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ENA713 | Drug | -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day. |
|
| Change From Baseline in Mini-Mental State Examination (MMSE) | The MMSE was used to measure severity of Alzheimer's disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. | Baseline and 24 weeks |
| Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly | The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3. | 4, 8, 12,16, 20 and 24 weeks |
| The Percentage of Treatment Retention. | Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings - 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks | Up to 24 weeks |
| Ōbu |
| Aichi-ken |
| 474-8511 |
| Japan |
| Novartis Investigative Site | Seto | Aichi-ken | 489-8642 | Japan |
| Novartis Investigative Site | Toyoake | Aichi-ken | 470-1168 | Japan |
| Novartis Investigative Site | Akita | Akita | 010-0874 | Japan |
| Novartis Investigative Site | Chiba | Chiba | 260-8712 | Japan |
| Novartis Investigative Site | Tōon | Ehime | 791-0295 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 814-0180 | Japan |
| Novartis Investigative Site | Fujioka | Gunma | 375-0017 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 734-8530 | Japan |
| Novartis Investigative Site | Miyoshi | Hiroshima | 728-0013 | Japan |
| Novartis Investigative Site | Kasama | Ibaraki | 309-1793 | Japan |
| Novartis Investigative Site | Kamakura | Kanagawa | 247-8533 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 212-0016 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 216-8511 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 252-5188 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 241-0811 | Japan |
| Novartis Investigative Site | Kochi | Kochi | 780-0842 | Japan |
| Novartis Investigative Site | Kochi | Kochi | 780-8037 | Japan |
| Novartis Investigative Site | Kōshi | Kumamoto | 861-1116 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 860-8556 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 861-8002 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 600-8558 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 607-8411 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 616-8255 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 982-8523 | Japan |
| Novartis Investigative Site | Kitamorokata-gun | Miyazaki | 889-1911 | Japan |
| Novartis Investigative Site | Azumino | Nagano | 399-8204 | Japan |
| Novartis Investigative Site | Matsumoto | Nagano | 399-8701 | Japan |
| Novartis Investigative Site | Nagaoka | Niigata | 940-2302 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 710-0826 | Japan |
| Novartis Investigative Site | Okayama | Okayama-ken | 700-8607 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 590-0018 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0874 | Japan |
| Novartis Investigative Site | Kanzaki-gun | Saga-ken | 842-0192 | Japan |
| Novartis Investigative Site | Kasukabe | Saitama | 344-0036 | Japan |
| Novartis Investigative Site | Kawaguchi | Saitama | 333-0832 | Japan |
| Novartis Investigative Site | Koshigaya | Saitama | 343-0032 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 338-0003 | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | 420-8688 | Japan |
| Novartis Investigative Site | Shizuoka | Shizuoka | 424-8636 | Japan |
| Novartis Investigative Site | Tokushima | Tokushima | 770-8503 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 193-0998 | Japan |
| Novartis Investigative Site | Koto-ku | Tokyo | 136-0075 | Japan |
| Novartis Investigative Site | Musashino | Tokyo | 180-8610 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 143-0016 | Japan |
| Novartis Investigative Site | Tachikawa | Tokyo | 190-8531 | Japan |
| Novartis Investigative Site | Shimonoseki | Yamaguchi | 752-8510 | Japan |
3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
| Safety Population (SAF) |
|
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Randomized set (RAN) The RAN consisted of all randomized patients. Patients were analyzed according to the treatment group they were assigned to at randomization. A patient was diagnosed of dementia with Lewy Bodies, different from AD, after randomization and was excluded from all analysis (SAF and FAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine Patch 1 Step | 1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day |
| BG001 | Rivastigmine Patch 3 Step | 3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day. |
| 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Baseline characteristics is based on safety analysis set therfore female number is 76. | Number | 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 | Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation | The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period. | Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline. | Posted | Number | Percentage of participants | Up to 24 weeks |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog) | The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline. | Full analysis set (FAS): includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 8,16, and 24 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mini-Mental State Examination (MMSE) | The MMSE was used to measure severity of Alzheimer's disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. | Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and 24 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With "Improvement": a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly | The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3. | Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit. | Posted | Number | Participants | 4, 8, 12,16, 20 and 24 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | The Percentage of Treatment Retention. | Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings - 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks | Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline. Patients were analyzed according to the treatment group they were assigned to at randomization. | Posted | Number | Percentage of Participants | Up to 24 weeks |
|
|
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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 1-step | Rivastigmine patch 1-step | 9 | 107 | 69 | 107 | ||
| EG001 | Rivastigmine Patch 3-step | Rivastigmine patch 3-step | 10 | 108 | 68 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dyslalia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | 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 or disclosure of trial results in their entirety
| 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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