UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036381 |
|---|---|
| Receipt number | R000041449 |
| Scientific Title | Effect of supplement involved ferulic acid, glycerophosphocholine, ginkgo leaf extract and vitamin C on mild cognitive impairment. -Before after study- |
| Date of disclosure of the study information | 2019/04/04 |
| Last modified on | 2020/08/07 09:39:29 |
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Basic information
Public title
Effect of supplement involved ferulic acid, glycerophosphocholine, ginkgo leaf extract and vitamin C on mild cognitive impairment. -Before after study-
Acronym
A clinical trial to study the effect of supplement on mild cognitive impairment.
Scientific Title
Effect of supplement involved ferulic acid, glycerophosphocholine, ginkgo leaf extract and vitamin C on mild cognitive impairment. -Before after study-
Scientific Title:Acronym
A clinical trial to study the effect of supplement on mild cognitive impairment.
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the supplement on cognitive function of MCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MMSE
(0day,90days and 180 days)
Key secondary outcomes
ABC dementia scale
POMS2
Blood apolipoprotein E
(0day,90days and 180 days)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food:tablet (ferulic acid, glycerophosphocholine, ginkgo leaf extract, VC)
Administration period:180days
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
| 55 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 55 to 74 years old at the time of the informed consent.
2. Subject who agree with the criterion of the mild cognitive impairment by a DSM-5.
3. MMSE score is more than 24 less than 27 at the time of before ingestion.
4. Z-score using the VSRAD is less than 1.0 on head MRI.image.
5. Subject who has an informant who understands the daily living condition of the person under test
6. Subjects and informants who giving written informed consent.
Key exclusion criteria
1) Subjects who constantly use Kampo preparation affecting cognitive function or dementia.
2) Subjects who constantly use supplements preparation affecting cognitive function or dementia.
3) Subjects who have psychiatric disorder affecting cognitive function or dementia with the exception of complete remission.
4)Subjects who take medical treatment for psychoneurosiswith antipsychotic drug.
5) Subjects with metabolic disease affecting cognitive function or dementia.
6) Subjects with liver disease, renal disease or hypoactivity of renal function (eGFR<=20 mL/min).
7) Subjects with uncontrolled type 2 diabetes or received insulin treatment.
8) Subjects with chronic obstructive lung disease and oxygen therapy in home or FEV1<30%.
9) Subjects with essential hypertension or uncontrolled hyperlipidemia.
10) Subjects who have medical history of gastrointestinal surgery or hospitalization for head injury within 10 years.
11) Subjects who have history of intracerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy, cardiac failure, ischemic heart disease, nephrosclerosis, aortic dissection or cerebral infarction.
12) Subjects with structural diseases with a possibility related to recognition dysfunction in the head MRI image acquired within 1 year before agreement acquisition or the first time check point.
13) Subjects who take medical treatment for cancer.
14) Subjects who are planned to participate in other clinical study.
15) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shunichi |
| Middle name | |
| Last name | Hikita |
Organization
Medical corporation ART
Division name
Chief Director
Zip code
204-0004
Address
Yamato clinic mall, II-3F, 2-11-29, Tsuruma, Yamato, Kanagawa, Japan
TEL
046-204-5551
Tsuruma-lilac@lilac.plala.or.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishiura |
Organization
Mebix, Inc
Division name
Research Promotion Head Office
Zip code
105-0001
Address
Toranomon 33 MORI Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
ferulic-a@mebix.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Adachikyousai Hospital Second Institutional Review Board
Address
1-36-8, Yanagihara, Adachi-ku, Tokyo, JAPAN
Tel
03-6721-5432
yama.chike2@gmail.com
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
医療法人エイ・アール・ティー会 ライラッククリニック
医療法人エイ・アール・ティー会 セントゼビアクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 04 | 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
| 2019 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041449
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