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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022219
Receipt No. 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

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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&#39;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&#39;s disease, Huntington&#39;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
Email 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
Email nakano.satomi@bell-medical.co.jp

Sponsor
Institute KAKU Neurosurgery clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025594

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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