An interventional study of Pitavastatin and cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) in Alzheimer Disease and Hypercholesterolemia, sponsored by Osaka University. Terminated at 1 site in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-06-14.
Sponsored by Osaka University · Not applicable, Interventional, and Treatment
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.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 38 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Osaka University is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Drug: Pitavastatin
Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
2 mg by orally/day Duration: 12 months
duration: 12 months
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
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.
Time frame: baseline and 12 months
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)
Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)
Time frame: baseline and 12 months
| Milestone | Pitavastatin | Cholesterol-lowering Medicine Other Than Statin |
|---|---|---|
| Started | 18 | 20 |
| Completed | 17 | 16 |
| Not completed | 1 | 4 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Physician decision | 1 | 1 |
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.
| scores on a scale | Pitavastatin | Cholesterol-lowering Medicine Other Than Statin |
|---|---|---|
| baseline | 18.59 ± 6.13 | 19.50 ± 5.61 |
| 12month | 20.20 ± 9.31 | 20.59 ± 7.91 |
Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pitavastatin | — | 0/18 (0%) | 0/18 (0%) |
| Cholesterol-lowering Medicine Other Than Statin | — | 0/20 (0%) | 0/20 (0%) |
| Age Continuous(years) | Pitavastatin | Cholesterol-lowering Medicine Other Than Statin | Total |
|---|---|---|---|
| Mean | 75.8 ± 7.2 | 75.3 ± 7.7 | 75.5 ± 7.4 |
| Sex: Female, Male(Participants) | Pitavastatin | Cholesterol-lowering Medicine Other Than Statin | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 1 | 2 | 3 |
This study is terminated, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pitavastatin
Osaka University