UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013231 |
|---|---|
| Receipt number | 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 12:11:22 |
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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
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
m-yukiko@rk9.so-net.ne.jp
Sponsor or person
Institute
Department of Geriatric Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015440
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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