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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020894
Receipt No. 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

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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
Email 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
Email ferulic-a@mebix.co.jp

Sponsor
Institute FANCL Corporation Research Institute
Institute
Department

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
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 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
URL(English) https://upload.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


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