UMIN-CTR Clinical Trial

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
Email	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
Email	ferulic-a@mebix.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041449