Alzheimer Disease Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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