Unique ID issued by UMIN | UMIN000014945 |
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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 |
Effect of plasmalogen-containing food on cognitive function in patients with mild Alzheimer's disease or mild cognitive impairment -a double blind trial-
Effect of plasmalogen-containing food on cognitive function in patients with Alzheimer's disease or mild cognitive impairment
Effect of plasmalogen-containing food on cognitive function in patients with mild Alzheimer's disease or mild cognitive impairment -a double blind trial-
Effect of plasmalogen-containing food on cognitive function in patients with Alzheimer's disease or mild cognitive impairment
Japan |
Alzheimer's disease
Neurology |
Others
NO
To evaluate the effects on the improvement of cognitive function and the plasmalogen hemodynamic alteration by 6-month administration of plasmalogen -containing food
Efficacy
Cognitive function test (Mini Mental State Examination)
1.Cognitive function test (Wechsler Memory Scale-Revised)
2.Blood Plasmalogen
3.Geriatric Depression Scale-Short Version
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
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
To administer the placebo food twice a day for 6 months and observe the changes of MMSE and other medical indices
60 | years-old | <= |
85 | years-old | > |
Male and Female
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
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
400
1st name | |
Middle name | |
Last name | Takehiko Fujino |
Plasmalogens Research Society
Clinical Division
6-18 Tenyamachi, Hakataku, Fukuoka
092-273-2411
info@pls.jp
1st name | |
Middle name | |
Last name | Chikako Wakana |
Plasmalogens Research Society
General Manager
6-18 Tenyamachi, Hakataku, Fukuoka
092-273-2411
wakana@pls.jp
Plasmalogens Research Society
Plasmalogens Research Society
Self funding
NO
2014 | Year | 10 | Month | 25 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 25 | Day |
2014 | Year | 10 | Month | 25 | Day |
2014 | Year | 08 | Month | 25 | Day |
2016 | Year | 08 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017387
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