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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009898
Receipt No. R000011600
Scientific Title Effect of plasmalogen -containing food on cognitive function in patients with Alzheimer disease - a single- blind trial -
Date of disclosure of the study information 2013/01/29
Last modified on 2013/01/29

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Basic information
Public title Effect of plasmalogen -containing food on cognitive function in patients with Alzheimer disease - a single- blind trial -
Acronym Alzheimer disease and plasmalogen
Scientific Title Effect of plasmalogen -containing food on cognitive function in patients with Alzheimer disease - a single- blind trial -
Scientific Title:Acronym Alzheimer disease and plasmalogen
Region
Japan

Condition
Condition Alzheimer disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects on the improvement of cognitive function and the plasmalogen hemodynamic alteration by 6-month administration of plasmalogen -containing food
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cognitive function test (MMSE)
Key secondary outcomes Levels of plasmalogen in the red cell
Blood chemical examination
Blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To administer the test food (the drink containing 0.5mg of plasmalogen) twice a day for 6 months and observe the changes of MMSE and other medical indices
Interventions/Control_2 To administer the test food (the drink containing 2.5mg of plasmalogen) twice a day for 6 months and observe the changes of MMSE and other medical indices
Interventions/Control_3 To administer the test food (the drink containing 5mg of plasmalogen) twice a day for 6 months and observe the changes of MMSE and other medical indices
Interventions/Control_4 To administer the placebo food twice a day for 6 months and observe the changes of MMSE and other medical indices
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Male and female who are 60 years old or above
2.Slight to moderate Alzheimer disease patients
3.Those who have received sufficient explanations on the trial and given an
Key exclusion criteria 1.Those who have bird allergy
2.Those who were judged unqualified by the responsible doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Tsuboi
Organization Fukuoka University Hospital
Division name Neurology
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Fukuoka University Hospital
Division name Neurology
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
Homepage URL
Email

Sponsor
Institute Bioennet corporation
Institute
Department

Funding Source
Organization Plasmalogen Inc.
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
2013 Year 01 Month 29 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 Preinitiation
Date of protocol fixation
2013 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 30 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
2013 Year 01 Month 29 Day
Last modified on
2013 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011600

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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