UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022222 |
|---|---|
| Receipt number | 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 14:53:19 |
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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
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
oguro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025504
