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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026268
Receipt No. 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

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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
Email 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
Email p2k07ll9@okayama-u.ac.jp

Sponsor
Institute Departments of Neurology, Dentistry and Pharmaceutical Sciences, Graduate School of Medicine, Okayama University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030164

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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