The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Alzheimer Disease, Hypercholesterolemia

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR 1 or 2) Patients with hypercholesterolemia Patients who have taken donepezil more than 3 months stably Both patients and care-givers must be more than 20 years old Exclusion Criteria: Women with pregnancy or breast-feeding Malignant tumor Cerebrovascular disorder or myocardial infarction prior to 12 weeks Heart failure [New York Heart Association (NYHA) class III or IV] Hepatic or renal dysfunction Severe hypertension Hypothyroidism, hereditary muscular disease, history of drug-induced myopathy Current involvement in another investigational drug study Alcoholism, drug abuse

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pitavastatin<br>* 2 mg by orally/day Duration: 12 months<br>|
| Active Comparator: 2<br> | Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)<br>* duration: 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pitavastatin, Statins, Donepezil, Alzheimer's Disease, Hypercholesterolemia, ADAS-Jcog, Alzheimer Disease (MMSE 15-23 and CDR1 or 2)