UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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	Kuniaki Bandoh
Organization	Jyunshin-kai medical corporation Bandoh clinic
Division name	Director
Address	514-8 Izumicho, Izumi-ku, Yokohama, Kanagawa, Japan
TEL	045-800-3934
Email	bandoh@bancli.com

Public contact
Name of contact person	Yuki Nishiura
Organization	Mebix, Inc.
Division name	Research Promotion Head Office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024107