The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease (PIT-ROAD)
|Alzheimer Disease Hypercholesterolemia||Drug: Pitavastatin Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) [ Time Frame: 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.
- 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) [ Time Frame: 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)
|Study Start Date:||November 2007|
|Study Completion Date:||March 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
2 mg by orally/day Duration: 12 months
|Active Comparator: 2||
Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
duration: 12 months
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548145
|Osaka University Hospital|
|Suita, Osaka, Japan, 565-0871|
|Principal Investigator:||Hiroaki Kazui, Ph.D.||Osaka University Hospital|