UMIN-CTR Clinical Trial

Basic information
Public title	The effects of Isaria japonica on cognitive function:An exploratory clinical study
Acronym	The effects of Isaria japonica on cognitive function
Scientific Title	The effects of Isaria japonica on cognitive function:An exploratory clinical study
Scientific Title:Acronym	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	1st name Hiroshi Middle name Last name Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	0542645102
Email	dfuru@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	0542645102
Homepage URL
Email	dfuru@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)

IRB Contact (For public release)
Organization	University of Shizuoka
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel	0542645102
Email	dfuru@u-shizuoka-ken.ac.jp

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

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	Completed
Date of protocol fixation	2018 Year 01 Month 10 Day
Date of IRB	2018 Year 12 Month 10 Day
Anticipated trial start date	2019 Year 02 Month 20 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 04 Day
Last modified on	2021 Year 11 Month 15 Day

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