UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of ingestion of reduced coenzyme Q10 in patients with mild cognitive impairment
Title of the study (Brief title)	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	Taisyoku Kaku
Organization	KAKU Neurosurgery clinic
Division name	Neurosurgery
Address	8-17, izumi-cho, Yamaguchi
TEL	083-920-1001
Email	kakutaisyoku@gmail.com

Public contact
Name of contact person	Satomi Nakano
Organization	Bell Medical Solutions Inc.
Division name	Clinical Research and Development
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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