UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015504
Receipt number R000017990
Scientific Title A open-label interventional multi-institutional joint research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients' brain.
Date of disclosure of the study information 2014/11/01
Last modified on 2020/05/02 16:10:33

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Basic information

Public title

A open-label interventional multi-institutional joint research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients' brain.

Acronym

A clinical research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients.

Scientific Title

A open-label interventional multi-institutional joint research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients' brain.

Scientific Title:Acronym

A clinical research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients.

Region

Japan


Condition

Condition

Mild Cognitive Impairment(MCI)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The objective is to assess the effect of ferulic acid and angelica archangelica on amyloid beta deposition in human brain and to examine their clinical benefit.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

We examine time-depending change of [11C]PiB amyloid positron emission tomography tracer bindings in MCI patients' brain at baseline, 12 months, and 24 months after taking "feru-guard 100M" (supplement including both ferulic acid and angelica archangelica extract).

Key secondary outcomes

1. We examine time-depending change of magnetic resonance imaging of the brain at baseline, 12 months, and 24 months after taking "feru-guard 100M".
2. We examine time-depending change of psychological test score with time, at baseline, 6 months, 12 months,18 months and 24 months after taking "feru-guard 100M". We also check the relationship between the test score and amyloid positron emission tomography imaging and/or magnetic resonance brain imaging.
3. We check the relationship between apolipoprotein E (ApoE) genetic variant and amyloid positron emission tomography imaging.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intervention group:
The subjects take orally one pack (1.5g) of "feru-guard 100M" before both breakfast and dinner every day for 24 months. One pack of "feru-guard 100M" includes 80mg ferulic acid and 20mg angelica archangelica extract.

Interventions/Control_2

Control group:
The subjects take no intervention.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects who fulfill the following all criteria.
1. Memory complaint by the subject (that is verified by a study partner) or by study partner.
Study partner is available who has
frequent contacts with the subject, and can accompany the subject on every visit for all durations of the protocol.
2. Decreased memory functions documented by scoring below the education adjusted cut-off on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale-Revised :
a) less than 9 for 16 or more years of educations.
b) less than 5 for 10-15 years of educations.
c) less than 3 for 0-9 years of educations.
3. Mini-Mental State Examination (MMSE) score between 24 and 30 (Exceptions may be permitted for subjects with less than 8 years of educations at the discretion of the project director).
4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5.
5. No depression.
6. Able to understand the research content and to sign the letter of informed consent by subject or study partner.
7. 20 years old or older (no upper limit of age).

Key exclusion criteria

Subject who applies to any of the following criteria will be rejected.
1. Combine any significant neuro- logical disease of dementia other than Alzheimer's disease.
2. Vascular dementia suspected by MRI, Hachinski score or NINDS-AIREN criteria.
3. Treatable dementia caused by metabolic disease, head trauma, normal pressure hydrocephalus (NPH), and so on.
4. Suspected psychiatric disorders, such as schizophrenia or major depression.
5. Cannot keep lying on bed for about 60 minutes.
6. Severe claustrophobia(fear of closed space).
7. MRI exclusions, such as presence of pacemaker or aneurysm clips.
8. Incapable of taking psychological test for any reason.
9. Any medication history of antidementia drugs or "feru- guard" series supplement.
10. Pregnant woman suspected by medical interview.
11. Other exceptions considered by project leader or collaborators.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Matsuyama

Organization

Kobe University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code

6500017

Address

7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan

TEL

078-382-6065

Email

matu054909@yahoo.co.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Matsuyama

Organization

Kobe University Graduate School of Medicine

Division name

Department of Psychiatry

Zip code

6500017

Address

7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan

TEL

078-382-6065

Homepage URL


Email

matu054909@yahoo.co.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Glovia Co., ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Institute of biomedical research and innovation, Kobe

Name of secondary funder(s)

Institute of biomedical research and innovation, Kobe


IRB Contact (For public release)

Organization

Kobe university hospital clinical research and translational research center

Address

7-5-2, Kusunoki-cho, chuo-ku, Kobe, Japan

Tel

078-382-6669

Email

chiken@med.kobe-u.ac.jp


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

神戸大学医学部附属病院(兵庫県)、先端医療センター病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 01 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

17

Results

There was no significant difference.

Results date posted

2019 Year 04 Month 30 Day

Results Delayed

Delay expected

Results Delay Reason

Need more time to complete the paper.

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

2014 Year 10 Month 03 Day

Date of IRB

2014 Year 08 Month 06 Day

Anticipated trial start date

2014 Year 11 Month 14 Day

Last follow-up date

2018 Year 03 Month 12 Day

Date of closure to data entry

2018 Year 03 Month 12 Day

Date trial data considered complete

2018 Year 03 Month 12 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 22 Day

Last modified on

2020 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017990


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name