NCT00548145

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Osaka University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Pitavastatin	2 mg by orally/day Duration: 12 months
DRUG	cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)	duration: 12 months

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-10-01
• Completion: 2012-03-01
• First posted: 2007-10-23
• Last updated: 2012-06-14
• Results posted: 2012-06-14

Locations

1 site across 1 country: Japan