UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002575 |
|---|---|
| Receipt number | R000003138 |
| Scientific Title | A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder |
| Date of disclosure of the study information | 2009/10/05 |
| Last modified on | 2021/10/11 13:41:03 |
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Basic information
Public title
A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder
Acronym
A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder
Scientific Title
A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder
Scientific Title:Acronym
A Double-Blind, Placebo-Controlled Study With 2-Docosahexaenoyl-3-Phosphatidylserine in Cognitive Disorder
Region
| Japan |
Condition
Condition
Cognitive Disorder
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effectiveness of 2-Docosahexaenoyl-3-Phosphatidylserine in treating cognitive disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Time Frame: 0, 12 weeks]
Key secondary outcomes
Profile of Mood States (POMS) [Time Frame: 0, 6,12 weeks]
Japanese Adult Reading Test (JART) [Time Frame: 0 week]
Brain CT or MRI [Time Frame: 0 week]
Serum Brain-Derived Neurotrophic Factor(BDNF) [Time Frame: 0, 12 weeks]
Food frequency questionnaire [Time Frame: 0 week]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
2-Docosahexaenoyl-3-Phosphatidylserine 100 mg/day (9 capsules/day) for 12 weeks
Interventions/Control_2
2-Docosahexaenoyl-3-Phosphatidylserine 300 mg/day (9 capsules/day) for 12 weeks
Interventions/Control_3
Placebo (9 capsules/day) for 12 weeks
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who are 55 years old or older without any physical impairment in daily life.
2. Those who have subjective memory impairment
3. Those aged between 55 and 59 whose total scores of RBANS are 220 or under, those aged between 60 and 69 whose scores are 200 or under, and those aged 70 or over whose scores are 180 or under.
Key exclusion criteria
1. Those aged between 55 and 64 whose scores of MMSE are under 21, those aged between 65 or over whose scores are under 18.
2. Those who, during the last 3 months, have continuously been taking central nervous system agent(s). However, those who have continuously been taking them at low dose levels as sleep-inducers are eligible.
3. Those who, during the last three months, have continuously been taking supplement(s) as follows: fish oils, phosphatidylserine, phosphatidylcholine or any other supplements which affect lipid metabolism.
4. Those suffering from alcoholism, schizophrenia, bipolar disorder or other psychiatric disorders.
5. Those suffering from other serious organic disease such as cancer.
6. Those who are allergic to marine products including cuttlefishes or octopuses.
7. Those who are considered not to be appropriate for the study by the doctor in charge of the present trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Hamazaki |
Organization
Polyene Project, Ltd.
Division name
Dept of Clinical Science
Zip code
Address
Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
TEL
076-434-7617
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Hamazaki |
Organization
Polyene Project, Ltd.
Division name
Dept of Clinical Science
Zip code
Address
Bunkyo-machi 3-3-8, Toyama-city, Toyama 9300876, Japan
TEL
076-434-7617
Homepage URL
keihama@med.u-toyama.ac.jp
Sponsor or person
Institute
Polyene Project, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Wakunaga Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 05 | 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
There was no statistically significant difference between groups.
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
| 2009 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003138
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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