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

Not Applicable

Terminated

• Conditions: Alzheimer Disease; Hypercholesterolemia
• Interventions: Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide); Drug: Pitavastatin

• Registration Number: NCT00548145
• Lead Sponsor: Osaka University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Study Start: 2007-11
• Primary Completion: 2011-10
• Results First Submitted: 2011-12-28
• Study Completion: 2012-03
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-14
• Last Update Submitted: 2012-05-14
• Results First Posted: 2012-06-14
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)	-
1	Pitavastatin	-

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)	baseline and 12 months	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.

Secondary Outcome Measures

Name	Time	Method
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)	baseline and 12 months	Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)

Trial Locations

Locations (1)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan