UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of the cognitive function and cerebral white matter lesions of pitavastatin in hypercholesterolemic patients with cognitive dysfunction.
Title of the study (Brief title)	the effect on the cognitive function and cerebral white matter lesions of pitavastatin in hypercholesterolemic patients with cognitive dysfunction
Region	Japan

Condition
Condition	Hypercholesterolemic patients with cognitive dysfunction
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect on cognitive function and cerebral white matter lesions of pitavastatin in hyperlipidemic patients with cognitive dysfunction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	.Change of cerebral white matter lesions(MRI) .Change of arteriosclerosis marker(PWV, IMT) .Change of cognitive function(MMSE) .Change of cerebral blood flow(SPECT) .Change of serum lipids
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pitavastatin Calcium(LIVALO) Taking a dose of 1-4mg once daily. Daily dose is determined based on Japan Atherosclerosis Society Guidelines 2012 for Prevension of Atherosclerotic Cardiovascular Diseases. Patients aged 75 years and over aim at less than LDL -C levels 140 mg/dL.
Interventions/Control_2	untreated group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Outpatients of Kyorin University Hospital Amnesia Center Judged that a lipid-lower therapy is required by Japan Atherosclerosis Society Guidelines 2012 for Prevention of Atherosclerotic Cardiovascular Diseases over 65 years old. 2.Patients who receive any statin can entry after 4 weeks washout periods. 3.the mild cognitive impairment to dementia patients.(15<=MMSE<=30) 4.PVH grade >=1/4 or DWMH grade >=1/4 (judged by two or more doctors) 5.Written informed consent is obtained from subjects or their family relatives or legally acceptable representatives before entry.
Key exclusion criteria	1.History of hypersensitivity to any of the ingredients of the product. 2.Severe hepatic disorder or biliary atresia. 3.Receiving cyclosporine. 4.Patients receiving fibrates who also have laboratory evidence of abnormal renal function. 5.Individuals who are ineligible in the opinion of the physician in charge.
Target sample size	60

Research contact person
Name of lead principal investigator	Koichi Kozaki
Organization	Kyorin University School of Medicine
Division name	Department of Geriatric Medicine
Address	6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL	0422-47-5511
Email	kourei@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Yukiko Moriya
Organization	Kyorin University School of Medicine
Division name	Department of Geriatric Medicine
Address	6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL	0422-47-5511
Homepage URL
Email	m-yukiko@rk9.so-net.ne.jp

Sponsor
Institute	Department of Geriatric Medicine, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	杏林大学医学部付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 02 Month 23 Day
Last modified on	2017 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015440