UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053824 |
|---|---|
| Receipt number | R000061411 |
| Scientific Title | A study of the effect of Isaria japonica on cognitive function in subjects with mild cognitive impairment: a randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2024/03/12 |
| Last modified on | 2024/03/11 11:22:32 |
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Basic information
Public title
A study of the effect of Isaria japonica on cognitive function in subjects with mild cognitive impairment: a randomized, double-blind, placebo-controlled study
Acronym
A study of the effect of Isaria japonica on cognitive function in subjects with mild cognitive impairment
Scientific Title
A study of the effect of Isaria japonica on cognitive function in subjects with mild cognitive impairment: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
A study of the effect of Isaria japonica on cognitive function in subjects with mild cognitive impairment
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine whether there is an improvement in cognitive function after supplementation with Isaria japonica for 6 months, and to obtain insights into the mechanism of action in humans
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
CogEvo and MMSE (after 6 months intervention)
Key secondary outcomes
CogEvo, MMSE (after 3 months intervention)
HDS-R, ADCS-ADL, GDS, AS, ABS, oxidative stress, cytokine levels, intestinal flora
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of Isaria japonica supplement (4 tablets) with (lukewarm) water, once daily after breakfast, for 6 months.
Interventions/Control_2
Intake of placebo (4 tablets) with (lukewarm) water, once daily after breakfast, for 6 months.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individual with forgetfulness, and an MMSE score of 24 or more
2. Age: from 40 to 75 years-old
3. Male or female, native Japanese speaker
Key exclusion criteria
1. Patients with diagnosed or suspected neurodegenerative disease that causes cognitive decline, such as Parkinson's disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, multiple sclerosis
2. Patients suspected of having cognitive disorder caused by metabolic disease (hypothyroidism, low vitamin B12, folate deficiency), head trauma, normal pressure hydrocephalus, epilepsy, or encephalitis/meningitis
3. History of major depression, bi-polar disorder, schizophrenia, or drug addiction such as alcoholism, or current serious or unstable disease
4. Individuals with onset of stroke within the past 90 days
5. Patients receiving pharmaceutical treatment with an antidementia drug
6. Currently taking supplements aimed at improving cognitive function (such as ginkgo leaves, DHA, curcumin, omega fatty acids, or vitamin B12), or having taken any of these products in the 1 month prior to IC
7. HbA1c 8.0 % or more
8. BMI 30 kg/m2 or more
9. Individuals who have difficulty performing cognitive/emotional assessments or motor function tests
10. Individuals with an MMSE score of 23 or less at the start of the study
11. Individuals judged unsuitable for the study by the recruiting physicians or investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Adachi |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Neurology, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka
TEL
093-641-7438
hiadachi@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Adachi |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Neurology, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka
TEL
093-641-7438
Homepage URL
hiadachi@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
DKS Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, University of Occupational and Environmental Health, Japan
Address
1-1 Iseigaoka, Yahata-nishi, Kitakyushu, Fukuoka
Tel
093-691-7127
rinshokenkyu@mbox.clnc.uoeh-u.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
| 2024 | Year | 03 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061411
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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