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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039796
Receipt No. R000044634
Scientific Title Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Date of disclosure of the study information 2020/03/31
Last modified on 2020/09/11

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Basic information
Public title Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Acronym Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Scientific Title Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Scientific Title:Acronym Evaluation of the effect of olfactory training on cognitive function in healthy adults.
Region
Japan

Condition
Condition Cognitive dysfunction
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of olfactory training with aromatherapy on memory function in healthy elderly subjects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes memory function ( a 24-week period)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 essential oil (rose odor, eucalyptus odor, lemon odor, and cloves odor)
Interventions/Control_2 essential oil (rosemary odor, lavender odor, lemon odor, and orange odor)
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 60 years or older
Key exclusion criteria subjects who were diagnosed with dementia and receiving treatment
Target sample size 24

Research contact person
Name of lead principal investigator
1st name SACHIKO
Middle name TANAKA
Last name TANAKA
Organization Tokyo University of Pharmacy and Life Sciences
Division name Department of Clinical Pharmacology
Zip code 192-0392
Address 1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
TEL 0426765796
Email sachiko@toyaku.ac.jp

Public contact
Name of contact person
1st name SACHIKO
Middle name TANAKA
Last name TANAKA
Organization Tokyo University of Pharmacy and Life Sciences
Division name Department of Clinical Pharmacology
Zip code 192-0392
Address 1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
TEL 0426765796
Homepage URL
Email sachiko@toyaku.ac.jp

Sponsor
Institute Tokyo University of Pharmacy and Life Sciences
Institute
Department

Funding Source
Organization Tokyo University of Pharmacy and Life Sciences
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 Tokyo University of Pharmacy and Life Sciences
Address 1432-1 Horinouchi, Hachioji, Tokyo 192-0392, Japan
Tel 0426765111
Email sakurai@toyaku.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 03 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
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
2020 Year 03 Month 31 Day
Date of IRB
2020 Year 01 Month 30 Day
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 03 Month 12 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044634

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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