The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease (PIT-ROAD)

Osaka University

Status: Terminated

Conditions: Alzheimer Disease; Hypercholesterolemia

Treatments: Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide); Drug: Pitavastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00548145

OSK-07098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Pitavastatin

2

Active Comparator group

Treatment:

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