The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease

Alzheimer Disease Clinical Trial

— PIT-ROAD  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00548145
• Other study ID #: OSK-07098
• Status: Terminated
• Phase: N/A
• First received: October 22, 2007
• Last updated: May 14, 2012
• Start date: November 2007
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Osaka University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Hypercholesterolemia

Intervention

Drug:
• Pitavastatin
2 mg by orally/day Duration: 12 months
• cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)
duration: 12 months

Locations

Country	Name	City	State
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
Osaka University	Kowa Company, Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 12 months	No
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)	baseline and 12 months	No

External Links

•   Link