UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020894 |
|---|---|
| Receipt number | R000024107 |
| Scientific Title | Effect of supplement involved ferulic acid, glycerophosphocholine and ginkgo leaf extract on mild cognitive impairment. -A randomized, double-blind, placebo-controlled, parallel-group clinical trial- |
| Date of disclosure of the study information | 2016/02/05 |
| Last modified on | 2017/04/27 10:13:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of supplement involved ferulic acid, glycerophosphocholine and ginkgo leaf extract on mild cognitive impairment.
-A randomized, double-blind, placebo-controlled, parallel-group clinical trial-
Acronym
A clinical trial to study the effect of ferulic acid on mild cognitive impairment
Scientific Title
Effect of supplement involved ferulic acid, glycerophosphocholine and ginkgo leaf extract on mild cognitive impairment.
-A randomized, double-blind, placebo-controlled, parallel-group clinical trial-
Scientific Title:Acronym
A clinical trial to study the effect of ferulic acid on mild cognitive impairment
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 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 for evaluation: 3 months, 6 months
Key secondary outcomes
ADAS-jcog(total, test), MMSE
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test food:tablet(ferulic acid, glycerophosphocholine, ginkgo leaf extract)
Administration period:180days
Interventions/Control_2
Control food:tablet(not contained ferulic acid, glycerophosphocholine, ginkgo leaf extract)
Administration period:180days
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Subjects with MCI and who meet the following criteria
Amnestic MCI
CDR 0 or 0.5
MMSE 22-26 and/or ADAS-jcog 5-15
2 Subjects who giving written informed consent
Key exclusion criteria
1) Subjects who use or plan to use go drugs affecting cognitive function or dementia.
2) Subjects who constantly use Kampo preparation affecting cognitive function or dementia.
3) Subjects who constantly use functional supplement affecting cognitive function or dementia.
4) Subjects who have psychiatric disorder (schizophrenia, mania, depression, severe cardiopathy, delirium, alcoholism etc.) affecting cognitive function or dementia with the exception of complete remission.
5) Subjects who take medical treatment for psychoneurosis (confusion, hallucination, delusion, abnormal behavior etc.) with antipsychotic drug.
6) Subjects with metabolic disease (hypothyroidism, deficiency of vitamin B12, etc.) affecting cognitive function or dementia.
7) Subjects with liver disease, renal disease or hypoactivity of renal function (eGFR<=20 mL/min).
8) Subjects with type 2 diabetes and HbA1c>8.4%, insulin treatment or taking drug for insulin secretion accelerating agent.
9) Subjects with chronic obstructive lung disease (COPD) and oxygen therapy in home or FEV1<30%.
10) Subjects with essential hypertension or uncontrolled hyperlipidemia.
11) Subjects who have medical history of gastrointestinal surgery or hospitalization for head injury within 10 years.
12) Subjects who have history of intracerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy･cardiac failure, ischemic heart disease(IHD), nephrosclerosis, aortic dissection, cerebral infarction.
13) Subjects who take medical treatment for cancer.
14) Subjects who are planned to participate in other clinical study.
15) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniaki Bandoh |
Organization
Jyunshin-kai medical corporation
Bandoh clinic
Division name
Director
Zip code
Address
514-8 Izumicho, Izumi-ku, Yokohama, Kanagawa, Japan
TEL
045-800-3934
bandoh@bancli.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Nishiura |
Organization
Mebix, Inc.
Division name
Research Promotion Head Office
Zip code
Address
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
03-4362-4500
Homepage URL
ferulic-a@mebix.co.jp
Sponsor or person
Institute
FANCL Corporation Research Institute
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人順神会 ばんどうクリニック
(Jyunshin-kai medical corporation Bandoh clinic)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 05 | 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
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 | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 03 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
