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

Results First Received: December 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Alzheimer Disease Hypercholesterolemia
Interventions:	Drug: Pitavastatin Drug: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Hyperlipidemia patients with mild to moderate Alzheimer’s disease(MMSE15～23)

Reporting Groups

	Description
Pitavastatin	2 mg by orally/day Duration: 12 months
Cholesterol-lowering Medicine Other Than Statin	duration: 12 months

Participant Flow: Overall Study

	Pitavastatin	Cholesterol-lowering Medicine Other Than Statin
STARTED	18	20
COMPLETED	17	16
NOT COMPLETED	1	4
Death	0	1
Withdrawal by Subject	0	2
Physician Decision	1	1

Baseline Characteristics

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Reporting Groups

	Description
Pitavastatin	2 mg by orally/day Duration: 12 months
Cholesterol-lowering Medicine Other Than Statin	duration: 12 months
Total	Total of all reporting groups

Baseline Measures

	Pitavastatin	Cholesterol-lowering Medicine Other Than Statin	Total
Number of Participants [units: participants]	18	20	38
Age [units: years] Mean ± Standard Deviation	75.8 ± 7.2	75.3 ± 7.7	75.5 ± 7.4
Gender [units: participants]
Female	17	18	35
Male	1	2	3

Outcome Measures

1. Primary:

Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) [ Time Frame: baseline and 12 months ]

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Measure Type	Primary
Measure Title	Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Pitavastatin	2 mg by orally/day Duration: 12 months
Cholesterol-lowering Medicine Other Than Statin	duration: 12 months

Measured Values

	Pitavastatin	Cholesterol-lowering Medicine Other Than Statin
Number of Participants Analyzed [units: participants]	17	16
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog) [units: scores on a scale] Mean ± Standard Deviation
baseline	18.59 ± 6.13	19.50 ± 5.61
12month	20.20 ± 9.31	20.59 ± 7.91

No statistical analysis provided for Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)

2. 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) [ Time Frame: baseline and 12 months ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Hiroaki Kazui,Ph.D.
Organization: Osaka University Hospital
phone: 81-6-6879-3051
e-mail: kazui@psy.med.osaka-u.ac.jp

No publications provided

Responsible Party:	Hiroaki Kazui, 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

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