UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for neurocognitive status improvement: A randomized double-blind placebo-controlled trial
Title of the study (Brief title)	The verification study for neurocognitive status improvement
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of improvements in neurocognitive status with the intake of test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Neuropsychological tests (Cognitrax)
Key secondary outcomes	1. Dementia Assessment Sheet in Community-based Integrated Care System (DASC-21) 2. Original questionnaire (Likert scale)

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	Duration: 12 weeks Test materials: Sea squirt-derived plasmalogen capsule Dose: 1 capsule, once a day Administration: Take 1 capsule per day any time during the day
Interventions/Control_2	Duration: 12 weeks Test materials: Placebo capsule Dose: 1 capsule, once a day Administration: Take 1 capsule per day any time during the day
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adults who feel memory loss 2. Those who are not dementia and are considered as appropriate for the study by the physician 3. Those who get 24 or more in score of MMSE 4. Those who have lower score in total score of Cognitrax
Key exclusion criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Those who have dementia 4. Those who have depression disorder, ADHD, or etc. such as mental illness 5. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 6. Currently taking medicines and/or herbal medicines 7. Those who take DHA or/and EPA-containing food in daily 8. Those who are allergic to medicines and/or the test food related products 9. Those who are pregnant, breast-feeding, and plan to become a pregnant 10. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 11. Others considered as inappropriate for the study by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	NIHON PHARMACEUTICAL CO., LTD. Sunsho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic
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	医療法人社団 盛心会 タカラクリニック (東京都) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 24 Day
Anticipated trial start date	2017 Year 02 Month 27 Day
Last follow-up date
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	2017 Year 02 Month 24 Day
Last modified on	2017 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030201