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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033966
Receipt No. R000038583
Scientific Title Brain function improving material (CogniUp) functional confirmation test
Date of disclosure of the study information 2018/08/31
Last modified on 2018/08/31

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Basic information
Public title Brain function improving material (CogniUp) functional confirmation test
Acronym CogniUp clinical trial
Scientific Title Brain function improving material (CogniUp) functional confirmation test
Scientific Title:Acronym CogniUp clinical trial
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Neurology Psychosomatic Internal Medicine Geriatrics
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to confirm the effects of cogny-up at 10.0 mg / day (0.1 mg / day for Huperzin A) on brain functions when ingested for 12 weeks for 36 healthy adult men and women who are concerned about forgetfulness.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy: FDG-PET, Cognytrax
Safety: Side effect occurrence rate
Evaluation period: 0, 6, 12 weeks

* 1, FDG-PET is measured after screening test and intake for 12 weeks
* 2, Cognytrax is measured after screening test and 0, 6, 12 weeks ingestion
Key secondary outcomes Effectiveness: Questionnaire
Safety: Adverse event incidence
Evaluation period: 0, 6, 12 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake the test food (CogniUp capsule) for 12 weeks
Interventions/Control_2 Intake the control food for 12 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Consent for participation in study Japanese men and women aged between 20 and under 80
2) Not applicable to the diagnostic criteria for dementia
3) Person who feels more forgetful than before
4) People who are healthy and are not currently treating any serious disease
5) Persons who can visit a designated medical institution on the scheduled arrival date
6) Those who agreed in writing after fully understanding the purpose and contents of this exam
Key exclusion criteria 1) Persons who regularly use health foods (including antioxidant effects, supplements with blood flow revision effect, etc.) intended to reduce brain function or forgetfulness
2) Persons who are difficult to participate in the examination due to liver, kidney, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, disturbance of consciousness, diabetes (according to the criteria established by the Japan Diabetes Association), epileptic seizures,
3) Treatment with stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, brain contusion, head injury Inpatient surgery
Those who have things
4) taking medications (such as antipsychotic drugs, anxiolytics, antidepressants, antiparkinsonism drugs, antidepressants, antiepileptic drugs, anticoagulant drugs, etc.) that are likely to affect the results of this study Who
5) Persons who are allergic to test foods
6) History of hepatitis, those with current medical history, cardiovascular disease, those with advanced anemia
7) Persons who have experienced a feeling defect or physical condition deterioration due to blood sampling in the past
8) Those who donated 200 mL or more from the beginning of the test until the start of the test or those who have the schedule during the test period
9) Participating in other clinical trials or within 4 weeks after the exam
10) Alcohol drinkers and excessive smokers
11) Extremely irregular eating habits
12) A person who can not agree with the purpose of this test conducted in advance
13) Those who have received neuropsychological tests etc. within the hospital within the past 3 months
14) Person who judged that examination responsible doctor is not appropriate for this study participation.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Shiojima
Organization Ryusendo Co., Ltd.
Division name President and CEO
Zip code
Address 1-5-3 Nishiikebukuro, Toshima-ku, Tokyo
TEL 03-3985-8346
Email y.shiojima@ryusendo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Takahashi
Organization Ryusendo Co., Ltd.
Division name Development Office
Zip code
Address 1-5-3 Nishiikebukuro, Toshima-ku, Tokyo
TEL 03-3985-8346
Homepage URL
Email m.takahashi@ryusendo.co.jp

Sponsor
Institute Akanuma surgical clinic
Institute
Department

Funding Source
Organization Ryusendo 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 赤沼外科医院(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 31 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 No longer recruiting
Date of protocol fixation
2018 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2018 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038583

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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