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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035765
Receipt No. R000040722
Official scientific title of the study The effects of Isaria japonica on cognitive function:An exploratory clinical study
Date of disclosure of the study information 2019/02/04
Last modified on 2019/02/04

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Basic information
Official scientific title of the study The effects of Isaria japonica on cognitive function:An exploratory clinical study
Title of the study (Brief title) The effects of Isaria japonica on cognitive function
Region
Japan

Condition
Condition Cognitive impairment
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of Isaria japonica-containing food on cognitive function for people with mild cognitive decline
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of mini-mental state examination (MMSE) score
Key secondary outcomes 1)Changes in domain of MMSE score
2)Changes of oxidative stress, inflammatory, dementia related markers
3)Changes of behavioral and psychological symptoms of dementia (BPSD)
4)Changes of quality of life (QOL)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Period of intervention 12 weeks,
Health Supplement Cordyceps,
Intake twice a day after dinner in the morning and evening
Interventions/Control_2
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) A person have mild cognitive decline: MMSE score 20-27 point
2) Prior to the research participation, the applicant and the person in charge of the document have obtained consent from the documents.
3) Age is 60 years old or older
4) A person who can cooperate in the intake and investigation of 12-week trial food
5) A person who can forbid the intake of supplements that affect the cognitive function one week before intake and during the intake period
Key exclusion criteria 1)A person who are allergic to cordyceps or silk or mushrooms
2) A person who has severe cardiac or and liver or renal function decline
3) A person who is taking dementia treatment drugs
4) A person who is given priority in drug treatment or surgical treatment as a cause of cognitive decline
5) A person who is judged unfit by the physician in charge of this study
Target sample size 30

Research contact person
Name of lead principal investigator Hiroshi Yamada
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL +81-54-264-5762
Email hyamada@u-shizuoka-ken.ac.jp

Public contact
Name of contact person Hiroshi Yamada
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL +81-54-264-5762
Homepage URL
Email hyamada@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

Funding Source
Organization Biococoon Laboratories, Inc.
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
2019 Year 02 Month 04 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 02 Month 20 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
2019 Year 02 Month 04 Day
Last modified on
2019 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040722

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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