Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00548145
Status:
TERMINATED
Last Update Posted:
2012-06-14
First Post:
2007-10-22
Brief Title:
The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimers Disease
Sponsor:
Osaka University
Organization:
Osaka University
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIT-ROAD
Brief Summary:
Some studies suggest that statin medications may be effective against Alzheimers 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 Alzheimers 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 andor blood sample all visits Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months
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 andor blood sample all visits Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None