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| ID | Type | Description | Link |
|---|---|---|---|
| GAL-KOR-024 | Other Identifier | Janssen Korea, Ltd., Korea | |
| GALALZ4045 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this study is to demonstrate that the change of attention measure is correlated with the changes of caregiver's burden after treatment with galantamine.
This is an open-label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multi-center (study conducted at multiple sites) study. The study mainly consists of 2 phases including, the screening phase (14 days before administration of study medication) and treatment phase (16 weeks). In the treatment phase, patients will receive galantamine 8 mg/day for the first 4 weeks and later on the dose will be increased up to 24mg (if tolerable). Safety evaluations will include assessment of adverse events. The total duration of the study will be 18 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galantamine | Patients will receive galantamine 8 mg/day for the first 4 weeks and the dose of galantamine will be increased up to 24 mg (if tolerable). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine | Drug | This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant. | Baseline (Week 1 [Day 1]), Week 16 |
| Change From Baseline at Week 16 in Burden Interview (BI) Scores | BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening. | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Alzheimer's disease
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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Out of 1,882 participants, 489 participants violated the inclusion/exclusion criteria and were excluded from the full analysis set (FAS). 1,472 participants completed the study. Total 1,393 participants were included in the FAS population.
1,882 participants were recruited to the 84 study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galantamine | Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were determined in Full Analysis Set (FAS) population. Out of 1,882 enrolled participants, 1,393 participants were included in the FAS and 489 participants were excluded due to violation of the inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Galantamine | Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks. |
| Units | Counts |
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| 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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| Severity of symptoms of dementia | Dementia is a general term for a decline in mental ability severe enough to interfere with daily life. Some of the most common form of dementia is Alzheimer's disease. The severity of dementia is divided as: (1) Suspected dementia (it is also named as Pre-dementia - often mistakenly attributed to ageing or stress), (2) Mild dementia, (3) Moderate dementia, (4) Sever dementia, and (5) Late (very severe) dementia. | Number | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS) | AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant. | FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Week 1 [Day 1]), Week 16 |
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| Primary | Change From Baseline at Week 16 in Burden Interview (BI) Scores | BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening. | FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 16 |
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| Secondary | Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE) | MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening. | FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 16 |
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Up to 16 weeks
Participants who received the study drug at least once were analysed. There was 9 serious adverse events in 7 participants were reported and no other adverse event in more than 5% of participants were reported.
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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 | Galantamine | Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks. | 7 | 1,882 | 0 | 1,882 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Death | General disorders | MedDRA version 15.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Jan-Cil Korea | 82 2 2094 | 4518 |
| 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 |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Severe dementia |
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| Late (very severe) dementia |
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| Mild dementia |
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