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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-03-31

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.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Pitavastatin

Intervention Type DRUG

2 mg by orally/day Duration: 12 months

2

Group Type ACTIVE_COMPARATOR

cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)

Intervention Type DRUG

duration: 12 months

Interventions

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Pitavastatin

2 mg by orally/day Duration: 12 months

Intervention Type DRUG

cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)

duration: 12 months

Intervention Type DRUG

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No