UMIN-CTR Clinical Trial

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