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This was a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.
This was a multicenter, prospective, single-arm, open-label, phase IV study to evaluate safety, tolerability and effectiveness of Rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician. Male and female patients who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent. The prescription decision was independent of the decision for inclusion in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine patch | Experimental | 15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine | Drug | 15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs. | Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mini-Mental State Examination (MMSE) | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); and results in a total score can range from 0 to 30, with higher scores indicating better function. | Baseline, 16 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 | Bangalore | Karnataka | 560 055 | India | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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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Participants who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent.
Participants took part in 9 investigative sites in India.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivastigmine Patch | 15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day |
| 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 | Dec 21, 2016 | Dec 8, 2023 |
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| Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score | Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence. | Baseline, 16 weeks |
| Compliance by Caregiver Medication Questionnaire (CMQ) Score | Caregiver evaluation of the medications used for Alzheimer Disease was assessed using the Caregiver Medication Questionnaire (CMQ). Compliance was rated on a scale from 0 = "never took the medication as prescribed" to 10 = "always took the medication as prescribed." | Week 16 |
| Number of Participants With a Skin Irritation | The following score system were used to assess skin irritation: I. Dermal response: Score 0 = No erythema (normal skin) Score 1 = Erythema barely visible Score 2 = Mild erythema Score 3 = Moderate erythema Score 4 = Severe erythema Score 5 = Severe erythema with vesicles or blisters | Week 16 |
| Number of Participants With a Urinary Tract Infection (UTI) | Urine samples were collected to assess the number of patients with UTI. | 16 weeks |
| Patch Adhesion to the Skin | Patch adhesion to the skin was evaluated by the caregiver. An estimate of the patch adherence was provided and graded according to the patch adhesiveness score. Following scores were used to capture comments relating to patch adhesion: 0 = 90 % adhered (essentially no lift off of the skin)
| Week 16 |
| Bangalore |
| Karnataka |
| 560052 |
| India |
| Novartis Investigative Site | Banglaore | Karnataka | 560052 | India |
| Novartis Investigative Site | Bengaluru | Karnataka | 560005 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400 053 | India |
| Novartis Investigative Site | Hyderabad | Telangana | 500082 | India |
| Novartis Investigative Site | Lucknow | Uttar Pradesh | 226003 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700017 | India |
| Novartis Investigative Site | Kolkata | West Bengal | 700054 | India |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivastigmine Patch | 15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day |
| 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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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | 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 | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs. | The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study. | Posted | Count of Participants | Participants | Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days. |
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| Secondary | Change From Baseline in Mini-Mental State Examination (MMSE) | The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); and results in a total score can range from 0 to 30, with higher scores indicating better function. | Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 16 weeks |
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| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score | Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence. | Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 16 weeks |
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| Secondary | Compliance by Caregiver Medication Questionnaire (CMQ) Score | Caregiver evaluation of the medications used for Alzheimer Disease was assessed using the Caregiver Medication Questionnaire (CMQ). Compliance was rated on a scale from 0 = "never took the medication as prescribed" to 10 = "always took the medication as prescribed." | Patients in the intend to treat (ITT) set who had a valid assessment of the outcome measure at week 16. The intend to treat (ITT) set included all patients who signed the informed consent and who had at least one post-baseline assessment. | Posted | Mean | Standard Deviation | Score on a scale | Week 16 |
|
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| Secondary | Number of Participants With a Skin Irritation | The following score system were used to assess skin irritation: I. Dermal response: Score 0 = No erythema (normal skin) Score 1 = Erythema barely visible Score 2 = Mild erythema Score 3 = Moderate erythema Score 4 = Severe erythema Score 5 = Severe erythema with vesicles or blisters | Patients in the safety set who had a dermal response score at week 16. The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study. | Posted | Number | participants | Week 16 |
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| Secondary | Number of Participants With a Urinary Tract Infection (UTI) | Urine samples were collected to assess the number of patients with UTI. | The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study. | Posted | Count of Participants | Participants | 16 weeks |
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| Secondary | Patch Adhesion to the Skin | Patch adhesion to the skin was evaluated by the caregiver. An estimate of the patch adherence was provided and graded according to the patch adhesiveness score. Following scores were used to capture comments relating to patch adhesion: 0 = 90 % adhered (essentially no lift off of the skin)
| Patients in the safety set who had a dermal response score at week 16. The safety set included all patients who provided informed consent to collect information and who were treated with at least one patch of Rivastigmine 27 mg -15 cm2 transdermal patch during this study. | Posted | Number | participants | Week 16 |
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Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.
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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 | 15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day | 2 | 100 | 4 | 100 | 16 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARRHYTHMIA | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| CEREBROSPINAL FLUID LEAKAGE | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| DEMENTIA | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| HYPONATRAEMIC SEIZURE | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VOMITING | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| SKIN IRRITATION | Skin and subcutaneous tissue disorders | MedDRA (20.1) | 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 | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2022 | Dec 8, 2023 | 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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| Title | Measurements |
|---|---|
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| At least one SAE |
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