UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of ferulic acid in the treatment of dementia (double-blinded study)
Title of the study (Brief title)	EFATD2
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy of ferulic acid in the treatment of mild cognitive impairment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ADAS-Jcog(pre-treatment and one year follow up)
Key secondary outcomes	Hasegawa Dementia Rating Scale, Mini Mental State Examination, Apathy scale,Self Depression Scale, FAB, ADAS-Jcog, Wechsler Memory Scale Revised, MRI(Default mode network,hippocampal atrophy)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	The treatment group is taking capsules of Ferulic Acid for 12 months.
Interventions/Control_2	The placebo group is taking capsules not containing Ferulic acid for 12 months.
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	89 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects with mild cognitive impairment are registered from Shimnane University Hospital and public subscripiton. MMSE is from 24 to 28.
Key exclusion criteria	metabolic encephalopathy(hypothyroidism),head trauma,malignancy,alcohl abuse, mental disorder,chronic renal failure, chronic heart failure,chronic liver injury and patients treated by major tranquilizer.
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroaki Oguro
Organization	Shimane University Hospital
Division name	Department of Neurology
Address	89-1 Enya-cho Izumo city Shimane
TEL	0853232111
Email	oguro@med.shimane-u.ac.jp

Public contact
Name of contact person	Hiroaki Oguro
Organization	Shimane University Hospital
Division name	Department of Neurology
Address	89-1 Enya-cho Izumo city Shimane
TEL	0853232111
Homepage URL
Email	oguro@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	GLOVIA
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	島根大学附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	This trial was done for mild cognitive impairment(MCI). There were not significant difference in MMSE, HDS-R, FAB(frontal assessment battery),hippocampal atrophy (MRI VSRAD) and ADAS-cog between ferulic acid group(n=37) and placebo group(n=41) for one year.
Other related information

Management information
Registered date	2016 Year 05 Month 06 Day
Last modified on	2018 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025504