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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002575
Receipt No. 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 2011/10/10

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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
Email

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
Email keihama@med.u-toyama.ac.jp

Sponsor
Institute Polyene Project, Ltd.
Institute
Department

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
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

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 Enrolling by invitation
Date of protocol fixation
2009 Year 08 Month 31 Day
Date of IRB
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
2011 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003138

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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