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This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil | Drug | 2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision. |
| Measure | Description | Time Frame |
|---|---|---|
| CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11). | 26 weeks |
| CERAD-K | CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatry Inventory (NPI) | NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihee Mun | Eisai Korea Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | South Korea | ||||
| Hallym University Medical Center |
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This study was recruited at 15 centers in Korea during the period of June 2006 to August 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Donepezil | Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 26 weeks |
| GDS-K (Geriatric Depression Scale-Korean) Score After Treatment | GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed. | 26 weeks |
| Changwon |
| South Korea |
| Kangwon National University Hospital | Chuncheon | South Korea |
| Kunkuk University Chungju Hospital | Chungju | South Korea |
| Kyungpook National University Hospital | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Gyeonggi Province Geriatric Hospital | Gyeonggi-do | South Korea |
| Uijeongbu St. Mary's Hospital | Gyeonggi-do | South Korea |
| Jeju National University Hospital | Jeju City | South Korea |
| Jeonju City Welfare Hospital | Jeonju | South Korea |
| Gyeongsang National University Hospital | Jinju | South Korea |
| Inje University Pusan Paik Hospital | Pusan | South Korea |
| Kunkuk University Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St. Mary's Hospital | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Donepezil | Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 (NIH/OMB) | 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 | CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) | CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11). | Posted | Mean | Standard Deviation | Units on Scale | 26 weeks |
|
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| Secondary | Neuropsychiatry Inventory (NPI) | NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances. | Posted | Mean | Standard Deviation | Units on Scale | 26 weeks |
|
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| Secondary | GDS-K (Geriatric Depression Scale-Korean) Score After Treatment | GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed. | Posted | Mean | Standard Deviation | Units on Scale | 26 weeks |
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| Primary | CERAD-K | CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition. | Posted | Mean | Standard Deviation | Second | 26 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 | Donepezil | Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day. | 4 | 199 | 30 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Psychiatric disorders |
| |||
| General Weakness | General disorders |
| |||
| Stroke | Vascular disorders |
| |||
| Ankle Fracture | Musculoskeletal and connective tissue disorders |
| |||
| Malignancy Of Unknown Origin | General disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness | General disorders |
| |||
| Anorexia | Psychiatric disorders |
| |||
| Abdominal Discomfort | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jihee Mun, Pharmacist, Medical team manager | Eisai Korea Inc. | +82-2-3451-5531 | jihee_mun@eisaikorea.com |
| 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 |
|---|---|
| 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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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
|
| Word List Memory |
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| Construction Praxis |
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| Word List Recall |
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| Word List Recognition |
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| Construction Recall |
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| Title | Denominators | Categories |
|---|
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| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Trail making test A |
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| Trail making test B |
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