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The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2020 | Drug | Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mini-mental State Examination (MMSE) Total | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. | Baseline, Week 52, and Week 52 LOCF |
| Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes. | Baseline, Week 52, and Week 52 LOCF |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Itaru Arimoto | New Product Development, Clinical Research Center, Eisai Co., Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | E2020 | Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | E2020 | Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Mini-mental State Examination (MMSE) Total | MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state. | Efficacy Analysis Set: subjects who received at least one dose of E2020 and also provided safety assessment data after baseline, with at least one available efficacy evaluation. Two subjects whose diagnosis was suspected not to meet clinical criteria of probable DLB and 2 subjects with lack of efficacy data were excluded from the efficacy analysis. | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 52, and Week 52 LOCF |
|
Up to 52 weeks
Other adverse events are listed at a frequency of 5% or greater
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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 | E2020 | Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA V14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA V14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masaki Nakagawa | Eisai Co., Ltd. | +81-3-3817-5245 | 5245 |
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Not eligible |
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| Prohibited Concomitant Medication |
|
| Physician Decision |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | Placebo/E2020 | Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group). |
|
|
| Primary | Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms | NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes. | Efficacy Analysis Set | Posted | Mean | Standard Deviation | Score on a Scale | Baseline, Week 52, and Week 52 LOCF |
|
|
|
| 8 |
| 108 |
| 53 |
| 108 |
| Psychiatric symptom | Psychiatric disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Poriomania | Psychiatric disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V14.0 | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA V14.0 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V14.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Gastrointestinal mucosal exfoliation | Gastrointestinal disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Radial nerve palsy | Nervous system disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V14.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA V14.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA V14.0 | Non-systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V14.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA V14.0 | Non-systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Pseudomembranous colitis | Infections and infestations | MedDRA V14.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA V14.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA V14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA V14.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA V14.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA V14.0 | Non-systematic Assessment |
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| Blood urine present | Investigations | MedDRA V14.0 | Non-systematic Assessment |
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| Protein urine present | Investigations | MedDRA V14.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA V14.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA V14.0 | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA V14.0 | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Week 52 LOCF |
|