UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009898 |
|---|---|
| Receipt number | 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 18:38:44 |
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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
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
Sponsor or person
Institute
Bioennet corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011600
