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

• Sponsor: Osaka University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00548145
• Collaborator: Kowa Company, Ltd. (Industry)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 52
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Hypercholesterolemia	Drug: Pitavastatin; Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Hiroaki Kazui, M.D.Ph.D, Osaka University
• ClinicalTrials.gov Identifier: NCT00548145
• Other Study ID Numbers: OSK-07098
• First Posted: Oct 23, 2007
• Last Update Posted: Jun 14, 2012
• Last Verified: May 1, 2012

• Keywords provided by Hiroaki Kazui, M.D.Ph.D, 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; Ezetimibe; Pitavastatin

Study Results

Participant Flow

Pre-assignment Detail	Hyperlipidemia patients with mild to moderate Alzheimer's disease(MMSE15～23)

Arm/Group Title	Pitavastatin	Cholesterol-lowering Medicine Other Than Statin
Arm/Group Description	2 mg by orally/day Duration: 12 months	duration: 12 months
Period Title: Overall Study
STARTED	18	20
COMPLETED	17	16
NOT COMPLETED	1	4

Baseline Characteristics

Arm/Group Title	Pitavastatin	Cholesterol-lowering Medicine Other Than Statin	Total
Arm/Group Description	2 mg by orally/day Duration: 12 months	duration: 12 months	Total of all reporting groups
Overall Participants	18	20	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	75.8 (7.2)	75.3 (7.7)	75.5 (7.4)
Sex: Female, Male (Count of Participants)
Female	17 94.4%	18 90%	35 92.1%
Male	1 5.6%	2 10%	3 7.9%

Outcome Measures

1. Primary Outcome

Title	Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pitavastatin	Cholesterol-lowering Medicine Other Than Statin
Arm/Group Description	2 mg by orally/day Duration: 12 months	duration: 12 months
Measure Participants	17	16
baseline	18.59 (6.13)	19.50 (5.61)
12month	20.20 (9.31)	20.59 (7.91)

2. Secondary Outcome

Title	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)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Pitavastatin		Cholesterol-lowering Medicine Other Than Statin
Arm/Group Description	2 mg by orally/day Duration: 12 months		duration: 12 months
All Cause Mortality
	Pitavastatin		Cholesterol-lowering Medicine Other Than Statin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pitavastatin		Cholesterol-lowering Medicine Other Than Statin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Pitavastatin		Cholesterol-lowering Medicine Other Than Statin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.