UMIN-CTR Clinical Trial

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