Alzheimer Disease, Hypercholesterolemia
Conditions
Keywords
Pitavastatin, Statins, Donepezil, Alzheimer's Disease, Hypercholesterolemia, ADAS-Jcog, Alzheimer Disease (MMSE 15-23 and CDR1 or 2)
Brief summary
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.
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 and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.
Interventions
DRUGPitavastatin
2 mg by orally/day Duration: 12 months
DRUGcholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
duration: 12 months
Sponsors
Kowa Company, Ltd.
Osaka University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR 1 or 2) * Patients with hypercholesterolemia * Patients who have taken donepezil more than 3 months stably * Both patients and care-givers must be more than 20 years old
Exclusion criteria
* Women with pregnancy or breast-feeding * Malignant tumor * Cerebrovascular disorder or myocardial infarction prior to 12 weeks * Heart failure \[New York Heart Association (NYHA) class III or IV\] * Hepatic or renal dysfunction * Severe hypertension * Hypothyroidism, hereditary muscular disease, history of drug-induced myopathy * Current involvement in another investigational drug study * Alcoholism, drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
Countries
Japan
Participant flow
Pre-assignment details
Hyperlipidemia patients with mild to moderate Alzheimer's disease(MMSE15～23)
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 2 mg by orally/day Duration: 12 months | 18 |
| Cholesterol-lowering Medicine Other Than Statin duration: 12 months | 20 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Pitavastatin | Cholesterol-lowering Medicine Other Than Statin | Total |
|---|---|---|---|
| Age Continuous | 75.8 years STANDARD_DEVIATION 7.2 | 75.3 years STANDARD_DEVIATION 7.7 | 75.5 years STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 20 |
| serious Total, serious adverse events | 0 / 18 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pitavastatin | Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | baseline | 18.59 scores on a scale | Standard Deviation 6.13 |
| Pitavastatin | Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | 12month | 20.20 scores on a scale | Standard Deviation 9.31 |
| Cholesterol-lowering Medicine Other Than Statin | Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | baseline | 19.50 scores on a scale | Standard Deviation 5.61 |
| Cholesterol-lowering Medicine Other Than Statin | Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) | 12month | 20.59 scores on a scale | Standard Deviation 7.91 |
Secondary
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