UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022219 |
|---|---|
| Receipt number | R000025594 |
| Scientific Title | Effect of ingestion of reduced coenzyme Q10 in patients with mild cognitive impairment |
| Date of disclosure of the study information | 2016/05/09 |
| Last modified on | 2017/09/22 18:10:17 |
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Basic information
Public title
Effect of ingestion of reduced coenzyme Q10 in patients with mild cognitive impairment
Acronym
Effect of ingestion of reduced coenzyme Q10 in patients with mild cognitive impairment
Scientific Title
Effect of ingestion of reduced coenzyme Q10 in patients with mild cognitive impairment
Scientific Title:Acronym
Effect of ingestion of reduced coenzyme Q10 in patients with mild cognitive impairment
Region
| Japan |
Condition
Condition
mild cognitive impairment
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the effect of a test food on mild cognitive impairment before and after ingestion of the test food or placebo
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Mini-Mental State Examination (MMSE) score before and after ingestion of the test food
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The treatment group will receive oral administration of reduced coenzyme Q10-containing soft capsules once daily.
Interventions/Control_2
The placebo group will receive oral administration of reduced coenzyme Q10-free soft capsules once daily.
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
(1) Age at the time of giving informed consent: 50 to 89 years
(2) Diagnosis: mild cognitive impairment or mild Alzheimer's-type dementia
(3) Patients should have an adequate understanding of the objectives and details of this study and the ability to give written informed consent for participation in the study either by themselves or via their respective legal representative.
Key exclusion criteria
(1) A score of 19 or less on the Revised Hasegawa Dementia Scale (HDS-R)
(2) Diagnosis of Parkinson's disease, Huntington's disease, multiple sclerosis, or epilepsy or the presence of head trauma
(3) Diagnosis of schizophrenia, depression, or serious heart disorder; incomplete recovery from a malignancy; or ongoing dialysis
(4) Treatment with oxidized coenzyme Q10 or reduced coenzyme Q10 within the last 2 months
(5) Judgment by the investigator as being ineligible to be a study subject for any other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taisyoku Kaku |
Organization
KAKU Neurosurgery clinic
Division name
Neurosurgery
Zip code
Address
8-17, izumi-cho, Yamaguchi
TEL
083-920-1001
kakutaisyoku@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi Nakano |
Organization
Bell Medical Solutions Inc.
Division name
Clinical Research and Development
Zip code
Address
1-3-7, Shiromi, Chuo-ku, Osaka
TEL
06-6920-7589
Homepage URL
nakano.satomi@bell-medical.co.jp
Sponsor or person
Institute
KAKU Neurosurgery clinic
Institute
Department
Personal name
Funding Source
Organization
Your Health Care Co.,Ltd.
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 05 | Month | 09 | 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
| 2016 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 06 | Day |
Last modified on
| 2017 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025594
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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