UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032734 |
|---|---|
| Receipt number | R000037273 |
| Scientific Title | Ameliorative effect of LOTORIGA on memory in elderly with hyperlipidemia |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2020/11/26 13:38:52 |
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Basic information
Public title
Ameliorative effect of LOTORIGA on memory in elderly with hyperlipidemia
Acronym
LOTORIGA study
Scientific Title
Ameliorative effect of LOTORIGA on memory in elderly with hyperlipidemia
Scientific Title:Acronym
LOTORIGA study
Region
| Japan |
Condition
Condition
hyperlipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To study the effect of LOTORIGA on cognitive function in patients with hyperlipidemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
cognitive function test score (Mini-mental state examination, Hasegawa dementia scale-revised, Severe impairment Battery), evaluation at 6 & 12 month after drug administration
Key secondary outcomes
serum lipid (LDL-C, HDL-C, TG), BDNF, Erythrocyte membrane fatty acid composition, evaluation at 6 & 12 month after drug administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prescribe Rotriga 2g per day or 4g per day for 1 year
Interventions/Control_2
observation without Rotriga for 1 year
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients diagnosed as having dyslipidemia (TG >= 150 mg/dl)
Key exclusion criteria
patients with hemorrhage, prescription of EPA drug, anticoagulants, NSAIDs excluding Aspirin, anti-acetylcholine esterase, supplements such as DHA or Beta-carotene
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nagai |
Organization
Shimane University, Faculty of Medicine
Division name
Department of Internal Medicine III
Zip code
693-8501
Address
89-1 Enya-cho, Izumo
TEL
0853202198
anagai@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Marina |
| Middle name | |
| Last name | Ikeda |
Organization
Shimane University, Faculty of Medicine
Division name
Department of Internal Medicine III
Zip code
693-8501
Address
89-1 Enya-cho, Izumo
TEL
0853202198
Homepage URL
cos3571@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Shimane University, Faculty of Medicine
Address
89-1 Enya-cho, Izumo
Tel
0853202515
i-kaih08@jn.shimane-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037273
