UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003683 |
|---|---|
| Receipt number | R000004463 |
| Scientific Title | The efficacy of ferulic acid in the treatment of dementia |
| Date of disclosure of the study information | 2010/05/31 |
| Last modified on | 2016/04/28 16:24:27 |
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Basic information
Public title
The efficacy of ferulic acid in the treatment of dementia
Acronym
EFATD
Scientific Title
The efficacy of ferulic acid in the treatment of dementia
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hiroaki Oguro |
Organization
Shimane University Hospital
Division name
Department of Neurology
Zip code
Address
Izumo city,Enya 89-1
TEL
0853202198
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
Izumo city
TEL
0853202198
Homepage URL
oguro@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
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
Name of secondary funder(s)
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
島根大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 31 | 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
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
| 2010 | Year | 05 | Month | 31 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004463
