UMIN-CTR Clinical Trial

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

Condition
Condition	Alzheimer's Disease, Dementia of Lewy Body,Vascular Dementia, Frontotemporal Dementia
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Hasegawa Dementia Rating Scale, Mini Mental State Examination, Electroencephalography, MRI,NPI(Neuropsychiatric Inventory),NPI-D(Neuropsychiatric Inventory Caregiver Distress Scale),Trail Making Test
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Taking of Ferulic Acid for 6 months followed by Not taking of Ferulic Acid for 6 months.
Interventions/Control_2	Not taking of Ferulic Acid for 6 months followed by taking of Ferulic Acid for 6 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Due to side effects dementia patients who can not take donepezil.
Key exclusion criteria	head trauma,malignancy,metabolic encephalopathy,alcohl abuse, Mental disorder,chronic renal failure and patients treated by major tranquilizer.
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroaki Oguro
Organization	Shimane University Hospital
Division name	Department of Neurology
Address	Izumo city,Enya 89-1
TEL	0853202198
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	Izumo city
TEL	0853202198
Homepage URL
Email	oguro@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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	島根大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 31 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2013 Year 04 Month 30 Day
Date of closure to data entry	2013 Year 04 Month 30 Day
Date trial data considered complete	2013 Year 05 Month 01 Day
Date analysis concluded	2013 Year 05 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 05 Month 31 Day
Last modified on	2016 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004463