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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015504
Receipt No. 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 2019/04/30

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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
Institute Kobe University Graduate School of Medicine
Institute
Department

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
2019 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 10 Month 22 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.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


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