UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Feru-guard 100M on the progression prevention of mild cognitive impairment associated
Title of the study (Brief title)	Effect of Feru-guard
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the Feru-Guard100M(ferulic acid supplement) on cognitive function of MCI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical Gloval Impression Criteria: Changes of cognitive impairment in comparison with before intervention. 1. Remarkable improvement of MCI 2. Improvement of MCI 3. No change 4. Hypofunction of cognitive Term: 24weeks, 48weeks
Key secondary outcomes	ADAS-jcog MMSE RBMT

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	Test food:capsule(ferulic acid, garden angelica) Administration period:48weeks
Interventions/Control_2	Test food:capsule(not contained ferulic acid, garden angelica) Administration period:48weeks
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	49 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. stuff forget there is complained of, that is supported by family and friends if possible 2. The general cognitive function is normal 3. housework and ADL, including the work it is generally normal 4. it is not a dementia 5.MMSE-J score more than 24 points 6.GDS-S-J is less than or equal to 5 points 7.ADAS-Jcog. Is less than or equal to 10 points or more three-point 8. MCIS score until the zero point below 49.8 points 9. Age is less than 85 years of age or 65 years of age
Key exclusion criteria	1. Patients who have merged the neurodegenerative disease which presents a dementia-like symptoms, or there is a suspicion Parkinson's disease, Huntington's disease, Down's syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, cortical basal degeneration, etc. 2. patient suspected failure in cognitive function due to causes of the following Vascular dementia, metabolic diseases (hypothyroidism, vitamin B12 hypothyroidism, folic acid deficiency, etc.), head trauma, normal pressure hydrocephalus 3. Patients with delirium due to drug addiction Patients 4. there is a history of the following disease onset before Alcoholism, stroke, depression, manic state, schizophrenia 5. malignant neoplasm, patients with acute inflammatory disease 6. Patients have experience taking Feru-guard in the past 7. Patients have medication anti-dementia drugs 8. CDR-J 1 or more 9. HbA1c 8.0 or higher 10. If clear metabolic syndrome 11. Other 12. If the principal investigator or researcher has determined that improper participation in the present study
Target sample size	140

Research contact person
Name of lead principal investigator	Tomokatsu Hori
Organization	SHIN-YURIGAOKA General Hospital
Division name	Cranial nerve surgery
Address	255 Hurusawa Aso-ku Kawasaki Kanagawa
TEL	044-322-9991
Email	tomokatsu.hori@mt.strins.or.jp

Public contact
Name of contact person	Shinya Yamamoto
Organization	Glovia Co., Ltd.
Division name	Department of clinical research
Address	2-9-6-7F Shinkawa Chuo-ku Tokyo
TEL	03-6228-3376
Homepage URL
Email	yamamoto@glovia.co.jp

Sponsor
Institute	Glovia Co., Ltd.
Institute
Department

Funding Source
Organization	Glovia Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 09 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 15 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025503