Unique ID issued by UMIN | UMIN000015504 |
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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 |
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.
A clinical research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients.
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.
A clinical research of the effect of ferulic acid and angelica archangelica extract on amyloid beta deposition in mild cognitive impairment patients.
Japan |
Mild Cognitive Impairment(MCI)
Psychiatry |
Others
YES
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
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).
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.
Interventional
Parallel
Non-randomized
Open -no one is blinded
No treatment
2
Treatment
Food |
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.
Control group:
The subjects take no intervention.
20 | years-old | <= |
Not applicable |
Male and Female
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).
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.
20
1st name | Kenichi |
Middle name | |
Last name | Matsuyama |
Kobe University Graduate School of Medicine
Department of Psychiatry
6500017
7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan
078-382-6065
matu054909@yahoo.co.jp
1st name | Kenichi |
Middle name | |
Last name | Matsuyama |
Kobe University Graduate School of Medicine
Department of Psychiatry
6500017
7-5-1, Kusunoki-cho, chuo-ku, Kobe, Japan
078-382-6065
matu054909@yahoo.co.jp
Kobe University Graduate School of Medicine
Glovia Co., ltd.
Profit organization
Japan
Institute of biomedical research and innovation, Kobe
Institute of biomedical research and innovation, Kobe
Kobe university hospital clinical research and translational research center
7-5-2, Kusunoki-cho, chuo-ku, Kobe, Japan
078-382-6669
chiken@med.kobe-u.ac.jp
NO
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)
2014 | Year | 11 | Month | 01 | Day |
Unpublished
17
There was no significant difference.
2019 | Year | 04 | Month | 30 | Day |
Delay expected |
Need more time to complete the paper.
Completed
2014 | Year | 10 | Month | 03 | Day |
2014 | Year | 08 | Month | 06 | Day |
2014 | Year | 11 | Month | 14 | Day |
2018 | Year | 03 | Month | 12 | Day |
2018 | Year | 03 | Month | 12 | Day |
2018 | Year | 03 | Month | 12 | Day |
2014 | Year | 10 | Month | 22 | Day |
2020 | Year | 05 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017990
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