The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease (PIT-ROAD)
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|ClinicalTrials.gov Identifier: NCT00548145|
Recruitment Status : Terminated
First Posted : October 23, 2007
Results First Posted : June 14, 2012
Last Update Posted : June 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Hypercholesterolemia||Drug: Pitavastatin Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||March 2012|
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548145
|Osaka University Hospital|
|Suita, Osaka, Japan, 565-0871|
|Principal Investigator:||Hiroaki Kazui, Ph.D.||Osaka University Hospital|