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The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2020 | Drug | Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3 | Visit 2 [Day1] and Visit 3 [Day 15] |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status | All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i | Visit 2 [Day1] and Visit 3 [Day 15] |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Naoki Kubota | Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akita | Akita | Japan | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | E2020 SR 23 mg | E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. |
| FG001 | E2020 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind |
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| E2020 | Drug | 10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase. |
|
| Fukuoka |
| Fukuoka |
| Japan |
| Kitakyushu | Fukuoka | Japan |
| Mizunami | Gifu | Japan |
| Yokosuka | Kanagawa | Japan |
| Sanjō | Niigata | Japan |
| Kurashiki | Okayama-ken | Japan |
| Saitama | Saitama | Japan |
| Fuji | Shizuoka | Japan |
| Hachiōji | Tokyo | Japan |
| Kodaira | Tokyo | Japan |
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
| COMPLETED |
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| NOT COMPLETED |
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| Extension |
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| ID | Title | Description |
|---|---|---|
| BG000 | E2020 SR 23 mg | E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. |
| BG001 | E2020 10 mg | E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Hachinski Score | The Hachinski Ischaemic Score (HIS) is an attempt to differentiate Alzheimer's type dementia and multi-infarct dementia. It uses a system of 13 features of with a score of 1 or 2, adding the scores together for a final score. A cut-off score less than or equal to 4 for Dementia of Alzheimer's Type (DAT) and greater than or equal to 7 for Vascular Dememntia (VaD) has a sensitivity of 89% and a specificity of 89%. | Mean | Standard Deviation | Scores on a Scale |
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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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status | All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | ng/mL | Visit 2 [Day1] and Visit 3 [Day 15] |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3 | Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma | Posted | Mean | Standard Deviation | ng/mL | Visit 2 [Day1] and Visit 3 [Day 15] |
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Up to 54 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 | E2020 SR 23 mg (Double-blind) | E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. | 0 | 22 | 13 | 22 | ||
| EG001 | E2020 10 mg (Double-blind) | E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. | 0 | 23 | 2 | 23 | ||
| EG002 | E2020 SR 23 mg (Extension) | E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. | 0 | 19 | 9 | 19 | ||
| EG003 | E2020 10 mg (Extension) | E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. | 1 | 23 | 16 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ataxia | Nervous system disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA V. 15.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA V. 15.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Epulis | Gastrointestinal disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA V. 15.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA V. 15.0 | Non-systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA V. 15.0 | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA V. 15.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA V. 15.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naoki Kubota | Clinical Development. JAC PCU. Eisai Co., Ltd. | +81-3-3817-5245 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D003693 | Delirium |
| D060825 | Cognitive Dysfunction |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Withdrawal of study drug 4 days in a row |
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| Physician Decision |
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| Prohibited concomitant medications |
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| Male |
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| Visit 3 EM [IR: n=16, SR: n=15] |
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| Visit 2 IM [IR: n=5, SR: n=3] |
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