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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019587
Receipt No. R000022641
Scientific Title The efficacy of reduced form of coenzyme Q10 in the Treatment of dementia
Date of disclosure of the study information 2015/11/01
Last modified on 2019/05/05

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Basic information
Public title The efficacy of reduced form of coenzyme Q10 in the Treatment of dementia
Acronym Coenzyme Q10 for dementia
Scientific Title The efficacy of reduced form of coenzyme Q10 in the Treatment of dementia
Scientific Title:Acronym Coenzyme Q10 for dementia
Region
Japan

Condition
Condition Demenita
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of Coenzyme Q10 in dementia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ADAS-J cog
(Term for evaluation:onset, 6 months,12 months)
Key secondary outcomes Neuropsychological Battery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Dosement of rcoenzyme Q10 300mg per a day and other anti-dementia drugs for 12 months.
Interventions/Control_2 Dosement of placebo per a day and other anti-dementia drugs 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
50 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria mild and moderate dementia
Key exclusion criteria Head trauma, Drug abuse, Alcoholism, Schizophrenia
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Oguro
Organization Shimane University Hospital
Division name Department of Neurology
Zip code 693-8501
Address 89-1 Enya-cho Izumo City,693-8501 Japan
TEL 0853-20-2343
Email cos3571@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Marina
Middle name
Last name Ikeda
Organization Shimane University Hospital
Division name Department of Neurology
Zip code 693-8501
Address 89-1 Enya-cho Izumo City,693-8501 Japan
TEL 0853-20-2199
Homepage URL
Email cos3571@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization KANEKA CORPORATION
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 Shimane University
Address 89-1 Enya-cho Izumo City,693-8501 Japan
Tel 0853-23-2111
Email oguro@med.shimane-u.ac.jp

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
2015 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 28 Day
Date of IRB
2016 Year 07 Month 25 Day
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 31 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022641

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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