UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014945 |
|---|---|
| Receipt number | 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 09:10:28 |
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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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017387
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
