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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024063
Receipt No. R000025503
Scientific Title Effect of Feru-guard 100M on the progression prevention of mild cognitive impairment associated
Date of disclosure of the study information 2016/09/15
Last modified on 2019/03/08

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Basic information
Public title Effect of Feru-guard 100M on the progression prevention of mild cognitive impairment associated
Acronym Effect of Feru-guard
Scientific Title Effect of Feru-guard 100M on the progression prevention of mild cognitive impairment associated
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomokatsu Hori
Organization SHIN-YURIGAOKA General Hospital
Division name Cranial nerve surgery
Zip code
Address 255 Hurusawa Aso-ku Kawasaki Kanagawa
TEL 044-322-9991
Email tomokatsu.hori@mt.strins.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Yamamoto
Organization Glovia Co., Ltd.
Division name Department of clinical research
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 08 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025503

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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