- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548145
The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease (PIT-ROAD)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Osaka
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Suita, Osaka, Japan, 565-0871
- Osaka University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
|
duration: 12 months
|
EXPERIMENTAL: 1
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2 mg by orally/day Duration: 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hiroaki Kazui, Ph.D., Osaka University Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Lipid Metabolism Disorders
- Dementia
- Tauopathies
- Hyperlipidemias
- Dyslipidemias
- Alzheimer Disease
- Hypercholesterolemia
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Ezetimibe
- Pitavastatin
Other Study ID Numbers
- OSK-07098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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