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| Name | Class |
|---|---|
| Kowa Company, Ltd. | INDUSTRY |
Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.
The PIT-ROAD study will include 50 patients who have taken donepezil more than 3 months stably. This study will see how the use of a particular statin medication, pitavastatin, affects ADAS-Jcog score etc. and cholesterol.
Participants will be given a full information of the study and written informed consent should be obtained before entering the study. Participants will take part in 5 visits over the course of 12 months. If participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. Participants will undergo 8 tests (ADAS-Jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | 2 mg by orally/day Duration: 12 months |
| |
| cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) |
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment. | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C) | Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC) | baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Kazui, Ph.D. | Osaka University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
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| Label | URL |
|---|---|
| Related Info | View source |
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Hyperlipidemia patients with mild to moderate Alzheimer's disease(MMSE15～23)
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin | 2 mg by orally/day Duration: 12 months |
| FG001 | Cholesterol-lowering Medicine Other Than Statin | duration: 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin | 2 mg by orally/day Duration: 12 months |
| BG001 | Cholesterol-lowering Medicine Other Than Statin | duration: 12 months |
| 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 | Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 12 months |
|
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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 | Pitavastatin | 2 mg by orally/day Duration: 12 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hiroaki Kazui,Ph.D. | Osaka University Hospital | 81-6-6879-3051 | kazui@psy.med.osaka-u.ac.jp |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| C417427 | colestimide |
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| Drug |
duration: 12 months |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C) | Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC) | Not Posted | baseline and 12 months |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Cholesterol-lowering Medicine Other Than Statin | duration: 12 months | 0 | 20 | 0 | 20 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |