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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022222
Receipt No. R000025504
Scientific Title The efficacy of ferulic acid in the treatment of dementia (double-blinded study)
Date of disclosure of the study information 2016/05/09
Last modified on 2018/11/07

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Basic information
Public title The efficacy of ferulic acid in the treatment of dementia (double-blinded study)
Acronym EFATD2
Scientific Title The efficacy of ferulic acid in the treatment of dementia (double-blinded study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroaki Oguro
Organization Shimane University Hospital
Division name Department of Neurology
Zip code
Address 89-1 Enya-cho Izumo city Shimane
TEL 0853232111
Email oguro@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Oguro
Organization Shimane University Hospital
Division name Department of Neurology
Zip code
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

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 島根大学附属病院

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
2014 Year 05 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025504

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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