UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024063
Receipt number 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 08:48:00

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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 or person

Institute

Glovia Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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