UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026268 |
|---|---|
| Receipt number | R000030164 |
| Scientific Title | Effect of antioxidant supplement TwendeeX on prevention of dementia |
| Date of disclosure of the study information | 2017/02/23 |
| Last modified on | 2020/02/25 17:07:39 |
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Basic information
Public title
Effect of antioxidant supplement TwendeeX on prevention of dementia
Acronym
Effect of TwendeeX on prevention of dementia
Scientific Title
Effect of antioxidant supplement TwendeeX on prevention of dementia
Scientific Title:Acronym
Effect of TwendeeX on prevention of dementia
Region
| Japan |
Condition
Condition
mild cognitive impairment
post stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of antioxidant supplement TwendeeX toward mild cognitive impairment or post-stroke patients on prevention of dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effect of TwendeeX on cognition (MMSE, HDS-R, and FAB) compared with Twendeex placebo at 6 months and 12 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
TwendeeX, 3 tablets at one time, at once a day, for 12 months
Interventions/Control_2
TwendeeX placebo, 3 tablets at one time, at once a day, 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
mild cognitive impairment (memory complaint, CDR=0.5, and 23<MMSE)
post stroke patinets with normal cognition or mild cognitive impairment (20<MMSE)
Key exclusion criteria
dementia due to diffuse Lewy body disease, frontotemporal lobe dementia, Huntington's disease, idiopathic normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, cotricobasal degeneration, multiple system atrophy, encephalitis, meningitis, head trauma
patients with major depression, bipolar disorder, alcoholism, drug dependence, or serious disorder.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Abe |
Organization
Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Division name
Departments of Neurology
Zip code
Address
2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7365
abekabek@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuta Morihara |
Organization
Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Division name
Departments of Neurology
Zip code
Address
2-5-1 Shikata-cho Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7365
Homepage URL
p2k07ll9@okayama-u.ac.jp
Sponsor or person
Institute
Departments of Neurology, Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Institute
Department
Personal name
Funding Source
Organization
TIMA Japan
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2017 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 22 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030164
