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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013231
Receipt No. R000015440
Scientific Title The effect of the cognitive function and cerebral white matter lesions of pitavastatin in hypercholesterolemic patients with cognitive dysfunction.
Date of disclosure of the study information 2014/03/01
Last modified on 2017/07/05

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Basic information
Public title The effect of the cognitive function and cerebral white matter lesions of pitavastatin in hypercholesterolemic patients with cognitive dysfunction.
Acronym the effect on the cognitive function and cerebral white matter lesions of pitavastatin in hypercholesterolemic patients with cognitive dysfunction
Scientific Title The effect of the cognitive function and cerebral white matter lesions of pitavastatin in hypercholesterolemic patients with cognitive dysfunction.
Scientific Title:Acronym 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
1st name
Middle name
Last name Koichi Kozaki
Organization Kyorin University School of Medicine
Division name Department of Geriatric Medicine
Zip code
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
1st name
Middle name
Last name Yukiko Moriya
Organization Kyorin University School of Medicine
Division name Department of Geriatric Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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