UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041869 |
|---|---|
| Receipt number | R000047790 |
| Scientific Title | The effect of improving cognitive function by olfactory training for older adults with healthy to mild cognitive impairment |
| Date of disclosure of the study information | 2020/09/26 |
| Last modified on | 2023/03/31 19:30:21 |
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Basic information
Public title
The effect of improving cognitive function by olfactory training for older adults with healthy to mild cognitive impairment
Acronym
The effect of improving cognitive function by olfactory training
Scientific Title
The effect of improving cognitive function by olfactory training for older adults with healthy to mild cognitive impairment
Scientific Title:Acronym
The effect of improving cognitive function by olfactory training
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of cognitive function improvement effect by olfactory training for older adults with healthy to mild cognitive impairment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Improvement of cognitive function
Key secondary outcomes
Improvement of activities of daily living
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
olfactory training
Once in the morning and evening
12 months
Interventions/Control_2
Control
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Mild Cognitive Impairment
Key exclusion criteria
Dementia, cognitive impairment due to brain disease, depression, schizophrenia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyano |
Organization
Kochi University
Division name
Public health
Zip code
7838505
Address
Oko-cho, Nankoku-shi, Kochi
TEL
0888802410
miyanoi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Miyano |
Organization
Kochi University
Division name
Public health
Zip code
7838505
Address
Oko-cho, Nankoku-shi, Kochi
TEL
0888802410
Homepage URL
miyanoi@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi University
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
Kochi University
Address
Oko-cho, Nankoku-shi, Kochi
Tel
0888802180
is21@kochi-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
| 2020 | Year | 09 | Month | 26 | 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
0
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
Terminated
Date of protocol fixation
| 2020 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2020 | Year | 09 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047790
