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To evaluate the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of Mini-Mental State Examination (MMSE) in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine Patch | Other | Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and will be up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine Patch | Drug | Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and will be up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label. |
| Measure | Description | Time Frame |
|---|---|---|
| MMSE Total Score: Change From Baseline to Week 8 and Week 24 (Full Analysis Set) | Evaluation of the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of MMSE in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs) The MMSE is a 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 from baseline. Abbreviated Scale title: Mini Mental State Evaluation Minimum Score: 0 Maximum score: 30 Higher score indicated better cognitive function | baseline, weeks 8 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| MMSE Total Score: Change From Baseline to Week 8 and Week 24 | Evaluation of the safety, tolerability of rivastigmine patch with 1-step titration for up to 24 weeks. Per Protocol, The MMSE is a brief, practical screening test for cognitive dysfunction. The MMSE consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, writing ability and reproduction of complex polygons), and the total possible score is 30. Lower score indicates more severe impairment. It is the most common and simple cognitive scale for Alzheimer's disease. Unabbreviated Scale : MMSE - Mini Mental State Evaluation: Minimum values - 0 Maximum value - 30 Higher Value means a better outcome Positive change score from baseline indicates improvement in cognitive function |
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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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fukuoka | Fukuoka | 814 0180 | Japan | ||
| Novartis Investigative Site |
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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In total, 147 patients were screened for the study. 129 completed screening and 18 discontinued from screening. 118 patients were enrolled and the remaining 11 patients discontinued at baseline.
All 118 enrolled patients received study treatment. 102 completed the study and 16 discontinued
The full analysis set (FAS) included all patients who received at least one dose of study treatment and had at least a baseline and any post-baseline assessment on treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine Patch | Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2016 | May 6, 2019 |
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| baseline, weeks 8 and 24 |
| Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE) Total Score | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the MMSE score at week 8 for patients who had 1-step titration MMSE total score: change from baseline to Week 8 and Week 24 for patients who had 1-step titration Unabbreviated Scale : MMSE - Mini Mental State Evaluation: Minimum values - 0 Maximum value - 30 Higher Value means a better outcome Positive change score from baseline indicates better outcome | baseline and week 8 |
| Change in Neuropsychiatric Inventory - 10 Item (NPI-10) Score From Baseline to Week 8 and Week 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the Neuropsychiatric Inventory - 10 Item (NPI-10) score at week 8 and week 24. Per protocol, Neuropsychiatric The NPI-10 total score is a sum of the 10 items, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains are equally weighted for the total score (thus the range for the total score is 0 to 120). A higher score indicates more severe impairment. Neuropsychiatry Inventory - 10 Minimum Score = 0 Maximum Score = 120 Higher Score indicates worse outcome | baseline, week 8, week 24 |
| Change in QOL-AD Score From Baseline to Week 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as QOL-AD score at week 24. Unabbreviated Scale Name: Quality of Life - Alzheimer's Disease Minimum Score = 13 Maximum Score = 52 Higher value indicates a better outcome QOL-AD is a 13-item questionnaire to assess the quality of life of Alzheimer's patients from the perspectives of patients and their caregivers. It covers several aspects, for example, the perception of health status, mood, functional capacity, personal relationships and leisure, financial situation, and life as a whole. Each item is quantified using a Likert scale with score one classified as poor, and score four as excellent where total scores range from 13 to 52. A lower score indicates more severe impairment. | baseline and week 24 |
| Change in J-CGIC Score From Baseline and at Week 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the The Japanese-Clinical Global Impression of Change (J-CGIC) score at baseline and week 24 J-CGIC is a 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 At week 24, 103 patients had available data Total score is in the 0 to 56 range. Higher score means more severe impairment. Unabbreviated scale title: Japanese -Cinical Global Impression of Change Minimum Score - 1 Maximum Score - 7 | baseline and week 24 |
| Change in as Modified Crichton Scale Score From Baseline to Week 4, 8, 16 and 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as Modified Crichton Scale score week 4, week 8, week 16, and week 24. Modified Crichton Scale that assess basic activation of daily living, communication functions, and quality of life The following 7 items will be evaluated by caregiver. Total score is in the 0 to 56 range. Higher score means more severe impairment. Unabbreviated Scale Title: Modified Crichton scale Minimum score = 0 Maximum Score = 56 Higher score indicates worse outcome | baseline, weeks 4, 8, 16, 24 |
| Formulation Usability Questionnaire Form Score up to Week 24 | Evaluation of the formulation usability of rivastigmine patch for up to 24 weeks as measured by the formulation usability questionnaire answered by caregiver. The Formulation usability preference questionnaire had been used to compare the previous oral AD drugs versus the patch The caregiver selects one of the following answers (1. Very easy to use, 2. Easy to use, 3. No change, 4. Not easy to use, 5. Not easy to use at all, 6. Unknown). This questionnaire data is used to assess if the usability of rivastigmine patch was preferred by the majority (> 50%) of AD patient caregivers or not. Unabbreviated Questionnaire title: Formulation Usability questionnaire Minimum Score = 1 Maximum Score = 6 A higher score indicates its not easy to use and worse outcome. | Up to week 24 |
| Fukuoka |
| Fukuoka |
| 814-0015 |
| Japan |
| Novartis Investigative Site | Aizu-Wakamatsu | Fukushima | 965-8585 | Japan |
| Novartis Investigative Site | Tsukuba | Ibaraki | 305-8576 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 252-5188 | Japan |
| Novartis Investigative Site | Kochi | Kochi | 780-0842 | Japan |
| Novartis Investigative Site | Sanjō | Niigata | 955-0823 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 710-0826 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 543-8555 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565 0871 | Japan |
| Novartis Investigative Site | Kasukabe | Saitama | 344-0036 | Japan |
| Novartis Investigative Site | Koshigaya | Saitama | 343-0032 | Japan |
| Novartis Investigative Site | Fuji | Shizuoka | 416-0955 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 113-8431 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 193-0944 | Japan |
| Novartis Investigative Site | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Novartis Investigative Site | Suginami Ku | Tokyo | 168-8535 | Japan |
| Novartis Investigative Site | Okayama | 710-0813 | Japan |
| COMPLETED |
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| NOT COMPLETED |
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FAS
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine Patch | Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 | MMSE Total Score: Change From Baseline to Week 8 and Week 24 (Full Analysis Set) | Evaluation of the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of MMSE in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs) The MMSE is a 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 from baseline. Abbreviated Scale title: Mini Mental State Evaluation Minimum Score: 0 Maximum score: 30 Higher score indicated better cognitive function | The full analysis set (FAS) included all patients who received at least one dose of study treatment and had at least a baseline and any post-baseline assessment on treatment | Posted | Mean | Standard Deviation | scores on a scale | baseline, weeks 8 and 24 |
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| Secondary | MMSE Total Score: Change From Baseline to Week 8 and Week 24 | Evaluation of the safety, tolerability of rivastigmine patch with 1-step titration for up to 24 weeks. Per Protocol, The MMSE is a brief, practical screening test for cognitive dysfunction. The MMSE consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, writing ability and reproduction of complex polygons), and the total possible score is 30. Lower score indicates more severe impairment. It is the most common and simple cognitive scale for Alzheimer's disease. Unabbreviated Scale : MMSE - Mini Mental State Evaluation: Minimum values - 0 Maximum value - 30 Higher Value means a better outcome Positive change score from baseline indicates improvement in cognitive function | Per Protocol Set (PPS): The per protocol set includes all patients in the FAS who had only 1 step titration without any major deviations from the protocol procedures | Posted | Mean | Standard Deviation | scores on a scale | baseline, weeks 8 and 24 |
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| Secondary | Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE) Total Score | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the MMSE score at week 8 for patients who had 1-step titration MMSE total score: change from baseline to Week 8 and Week 24 for patients who had 1-step titration Unabbreviated Scale : MMSE - Mini Mental State Evaluation: Minimum values - 0 Maximum value - 30 Higher Value means a better outcome Positive change score from baseline indicates better outcome | FAS | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 8 |
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| Secondary | Change in Neuropsychiatric Inventory - 10 Item (NPI-10) Score From Baseline to Week 8 and Week 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the Neuropsychiatric Inventory - 10 Item (NPI-10) score at week 8 and week 24. Per protocol, Neuropsychiatric The NPI-10 total score is a sum of the 10 items, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains are equally weighted for the total score (thus the range for the total score is 0 to 120). A higher score indicates more severe impairment. Neuropsychiatry Inventory - 10 Minimum Score = 0 Maximum Score = 120 Higher Score indicates worse outcome | FAS The number of participants analysed per row differs from overall number of participants because this is based on available data and patient continuation/discontinuation during that respective study period. | Posted | Mean | Standard Deviation | scores on a scale | baseline, week 8, week 24 |
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| Secondary | Change in QOL-AD Score From Baseline to Week 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as QOL-AD score at week 24. Unabbreviated Scale Name: Quality of Life - Alzheimer's Disease Minimum Score = 13 Maximum Score = 52 Higher value indicates a better outcome QOL-AD is a 13-item questionnaire to assess the quality of life of Alzheimer's patients from the perspectives of patients and their caregivers. It covers several aspects, for example, the perception of health status, mood, functional capacity, personal relationships and leisure, financial situation, and life as a whole. Each item is quantified using a Likert scale with score one classified as poor, and score four as excellent where total scores range from 13 to 52. A lower score indicates more severe impairment. | FAS The number of participants analysed per row differs from overall number of participants because this is based on available data and patient continuation/discontinuation during that respective study period. | Posted | Mean | Standard Deviation | scores on a scale | baseline and week 24 |
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| Secondary | Change in J-CGIC Score From Baseline and at Week 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the The Japanese-Clinical Global Impression of Change (J-CGIC) score at baseline and week 24 J-CGIC is a 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 At week 24, 103 patients had available data Total score is in the 0 to 56 range. Higher score means more severe impairment. Unabbreviated scale title: Japanese -Cinical Global Impression of Change Minimum Score - 1 Maximum Score - 7 | FAS | Posted | Count of Participants | Participants | baseline and week 24 |
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| Secondary | Change in as Modified Crichton Scale Score From Baseline to Week 4, 8, 16 and 24 | Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as Modified Crichton Scale score week 4, week 8, week 16, and week 24. Modified Crichton Scale that assess basic activation of daily living, communication functions, and quality of life The following 7 items will be evaluated by caregiver. Total score is in the 0 to 56 range. Higher score means more severe impairment. Unabbreviated Scale Title: Modified Crichton scale Minimum score = 0 Maximum Score = 56 Higher score indicates worse outcome | FAS The number of participants analysed per row (modified crichton scale) differs from overall number of participants because this is based on available data and patient continuation/discontinuation during that respective study period. | Posted | Mean | Standard Deviation | scores on a scale | baseline, weeks 4, 8, 16, 24 |
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| Secondary | Formulation Usability Questionnaire Form Score up to Week 24 | Evaluation of the formulation usability of rivastigmine patch for up to 24 weeks as measured by the formulation usability questionnaire answered by caregiver. The Formulation usability preference questionnaire had been used to compare the previous oral AD drugs versus the patch The caregiver selects one of the following answers (1. Very easy to use, 2. Easy to use, 3. No change, 4. Not easy to use, 5. Not easy to use at all, 6. Unknown). This questionnaire data is used to assess if the usability of rivastigmine patch was preferred by the majority (> 50%) of AD patient caregivers or not. Unabbreviated Questionnaire title: Formulation Usability questionnaire Minimum Score = 1 Maximum Score = 6 A higher score indicates its not easy to use and worse outcome. | FAS | Posted | Count of Participants | Participants | Up to week 24 |
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up 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 | Exelon/Rivastigmine Patch | Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and was up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label. | 0 | 118 | 5 | 118 | 57 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 (862) 778-8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2019 | May 6, 2019 | SAP_001.pdf |
| 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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