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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014945
Receipt No. R000017387
Scientific Title Effect of plasmalogen-containing food on cognitive function in patients with mild Alzheimer's disease or mild cognitive impairment -a double blind trial-
Date of disclosure of the study information 2014/10/25
Last modified on 2016/08/26

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Basic information
Public title Effect of plasmalogen-containing food on cognitive function in patients with mild Alzheimer's disease or mild cognitive impairment -a double blind trial-
Acronym Effect of plasmalogen-containing food on cognitive function in patients with Alzheimer's disease or mild cognitive impairment
Scientific Title Effect of plasmalogen-containing food on cognitive function in patients with mild Alzheimer's disease or mild cognitive impairment -a double blind trial-
Scientific Title:Acronym Effect of plasmalogen-containing food on cognitive function in patients with Alzheimer's disease or mild cognitive impairment
Region
Japan

Condition
Condition Alzheimer's 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 (Mini Mental State Examination)
Key secondary outcomes 1.Cognitive function test (Wechsler Memory Scale-Revised)
2.Blood Plasmalogen
3.Geriatric Depression Scale-Short Version

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To administer the test food containing 0.5 mg of plasmalogen twice a day for 6 months and observe the changes of MMSE and other medical indices
Interventions/Control_2 To administer the placebo food twice a day for 6 months and observe the changes of MMSE and other medical indices
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Informed consents are obtained in writing from patients or one of their caretakers
2. Those who regularly go to hospitals conducting this study and are 60 or more but less than 85 years old (regardless of gender)
3.Those whom the responsible doctor have diagnosed as mild Alzheimer's disease or mild cognitive impairment based on DSM5
4.Those who have showed 20 or more and 27 or less in the score of Mini Mental State Examination
5.Those who have showed 5 or less in the score of geriatric Depression scale-short Version
6. Those who have stayed on the same medications since 3 months before the study until it's termination if they have been prescribed
7. Those who are judged as suitable for participation in this study by responsible doctors at the beginning of the study
Key exclusion criteria 1. Those who have scallop allergy
2. Those who are judged as not suitable for participation in this study by responsible doctors at the beginning of the study
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiko Fujino
Organization Plasmalogens Research Society
Division name Clinical Division
Zip code
Address 6-18 Tenyamachi, Hakataku, Fukuoka
TEL 092-273-2411
Email info@pls.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chikako Wakana
Organization Plasmalogens Research Society
Division name General Manager
Zip code
Address 6-18 Tenyamachi, Hakataku, Fukuoka
TEL 092-273-2411
Homepage URL
Email wakana@pls.jp

Sponsor
Institute Plasmalogens Research Society
Institute
Department

Funding Source
Organization Plasmalogens Research Society
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
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
2014 Year 10 Month 25 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 Completed
Date of protocol fixation
2014 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 25 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
2014 Year 08 Month 25 Day
Last modified on
2016 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017387

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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