UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019587 |
|---|---|
| Receipt number | 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 15:20:28 |
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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
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
cos3571@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022641
