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The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease (PIT-ROAD)

This study has been terminated.
Sponsor:
Collaborator:
Kowa Company, Ltd.
Information provided by (Responsible Party):
Hiroaki Kazui, Osaka University
ClinicalTrials.gov Identifier:
NCT00548145
First received: October 22, 2007
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  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(e.g.,Ezetimibe,Colestimide)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Osaka University:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    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 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: baseline and 12 months ] [ Designated as safety issue: No ]
    Mini-Mental State Examination(MMSE),Geriatric Depression Scale-15(GDS-15),Instrumental Activities of Daily Living Scale(IADL),Total Cholesterol(TC)


Enrollment: 38
Study Start Date: November 2007
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Pitavastatin
2 mg by orally/day Duration: 12 months
Active Comparator: 2 Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
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

Locations
Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
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: Hiroaki Kazui, M.D.Ph.D, Osaka University
ClinicalTrials.gov Identifier: NCT00548145     History of Changes
Other Study ID Numbers: OSK-07098
Study First Received: October 22, 2007
Results First Received: December 28, 2011
Last Updated: May 14, 2012
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)

Additional relevant MeSH terms:
Alzheimer Disease
Hypercholesterolemia
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Pitavastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013