UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033966 |
|---|---|
| Receipt number | R000038583 |
| Scientific Title | Brain function improving material (CogniUp) functional confirmation test |
| Date of disclosure of the study information | 2018/08/31 |
| Last modified on | 2019/09/02 16:18:02 |
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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 | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
171-0021
Address
1-5-3 Nishiikebukuro, Toshima-ku, Tokyo
TEL
03-3985-8346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Office
Zip code
171-0021
Address
1-5-3 Nishiikebukuro, Toshima-ku, Tokyo
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Akanuma surgical clinic
Institute
Department
Personal name
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
Akanuma Surgeon Board Ethics Review Committee
Address
Ishiyama 2-jo 6-chome 14-1, Minami-ku, Sapporo-shi, Hokkaido
Tel
011-591-1777
s-ito@kyowa-t.com
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
35
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
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 12 | Day |
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
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038583
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