UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016008 |
|---|---|
| Receipt number | R000018608 |
| Scientific Title | Effect of plasmalogen-containing food on cognitive function in patients with dementia(except mild Alzheimer's disease) -an open trial- |
| Date of disclosure of the study information | 2014/12/19 |
| Last modified on | 2016/06/20 09:52:45 |
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Basic information
Public title
Effect of plasmalogen-containing food on cognitive function in patients with dementia(except mild Alzheimer's disease)
-an open trial-
Acronym
Effect of plasmalogen-containing food on cognitive function in patients with dementia
Scientific Title
Effect of plasmalogen-containing food on cognitive function in patients with dementia(except mild Alzheimer's disease)
-an open trial-
Scientific Title:Acronym
Effect of plasmalogen-containing food on cognitive function in patients with dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on the improvement of cognitive function by 3-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
Caretakers' objective evaluation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To devide participants into 2 groups, administer to each group the test food containing 0.5mg or 1.0mg of plasmalogen for 3 months and observe the changes of MMSE and caretakers' evaluation
Interventions/Control_2
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 older and 85 or younger Japanese (as of obtaining informed consent)
3.Those who showed 19 or less of Mini Mental State Examination at the beginning of this study
4.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
500
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
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
wakana@pls.jp
Sponsor or person
Institute
Plasmalogens Research Society
Institute
Department
Personal name
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
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 | 12 | Month | 19 | 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 | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | 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 | 12 | Month | 19 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018608
