The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	Osaka University Kowa Company, Ltd.
Information provided by:	Osaka University
ClinicalTrials.gov Identifier:	NCT00548145

Purpose

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.

Condition	Intervention
Alzheimer Disease Hypercholesterolemia	Drug: Pitavastatin Drug: cholesterol-lowering medicine other than statin

Genetics Home Reference related topics: Alzheimer disease hypercholesterolemia

MedlinePlus related topics: Alzheimer's Disease Cholesterol Statins

Drug Information available for: Pitavastatin NK 104

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Osaka University:

Primary Outcome Measures:

ADAS-Jcog [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Pitavastatin 2mg PO/day Duration: 12 months
2: Active Comparator	Drug: cholesterol-lowering medicine other than statin duration: 12 months

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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548145

Contacts

Contact: Hiroaki Kazui, Ph.D.

81-6-6879-3051

kazui@psy.med.osaka-u.ac.jp

Locations

Japan, Osaka
Osaka University Hospital	Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Hiroaki Kazui, M.D, Ph.D. +81-6-6879-3051 ext 3058 kazui@psy.med.osaka-u.ac.jp
Principal Investigator: Hiroaki Kazui, Ph.D.
Sub-Investigator: Hiromasa Tokunaga, Ph.D

Sponsors and Collaborators

Osaka University

Kowa Company, Ltd.

Investigators

Principal Investigator:

Hiroaki Kazui, Ph.D.

Osaka University Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Osaka University ( Hiroaki Kazui, PhD )
Study ID Numbers:	OSK-07098
Study First Received:	October 22, 2007
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00548145 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Osaka University:

Pitavastatin
Statins
Donepezil
Alzheimer's Disease

Hypercholesterolemia
ADAS-Jcog
Alzheimer Disease (MMSE 15-23 and CDR1 or 2)

Study placed in the following topic categories:

Hyperlipidemias
Metabolic Diseases
Alzheimer Disease
Central Nervous System Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders

NK 104
Mental Disorders
Donepezil
Dementia
Metabolic Disorder
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders
Delirium

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Molecular Mechanisms of Pharmacological Action
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Brain Diseases
Neurodegenerative Diseases

Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
NK 104
Mental Disorders
Dementia
Tauopathies
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009