UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041794 |
|---|---|
| Receipt number | R000047698 |
| Scientific Title | A multicenter, open-label, interventional study to verify for association between cognitive decline and olfactory disturbance using a DEmentia Screening Kit in subjects with normal cognitive function, mild cognitive impairment, and Alzheimer s dementia |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2021/08/05 17:42:47 |
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Basic information
Public title
A multicenter, open-label, interventional study to verify for association between cognitive decline and olfactory disturbance using a DEmentia Screening Kit in subjects with normal cognitive function, mild cognitive impairment, and Alzheimer s dementia
Acronym
DESK Study
Scientific Title
A multicenter, open-label, interventional study to verify for association between cognitive decline and olfactory disturbance using a DEmentia Screening Kit in subjects with normal cognitive function, mild cognitive impairment, and Alzheimer s dementia
Scientific Title:Acronym
DESK Study
Region
| Japan |
Condition
Condition
Healthy Person/Mild Cognitive Impairment/Alzheimer's Disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the relationship between olfactory deficits and cognitive impairment in healthy volunteers, persons with mild cognitive impairment, and patients with Alzheimer's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between cognitive impairment and olfactory deficits in subjects with healthy, mild cognitive impairment, and Alzheimer's disease.
1) Olfactory score by disease level
2) The relationship between olfactory scores and cognitive functioning indicators
3) Discriminability of disease levels using olfactory scores
Key secondary outcomes
1) The ability to diagnose disease levels using olfactory scores
2) Subgroup analysis by medical history and comorbidity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjects will be tested for olfaction using a total of 20 research substances including 10 fragrances and 2 concentrations each.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who meet all the inclusion criteria will be enrolled in this study.
1) Men and women between 40 and 90 years-old at the time of obtaining consent.
2) Subjects who meets any of the following criteria
A) Healthy volunteers: Subjects with a MMSE score of 28 or higher
B) Mild cognitive impairment: Subjects with a MMSE score of 24 or higher and 27 or lower who diagnosed with mild cognitive impairment and with dysmnesia by a dementia specialist based on the diagnostic criteria of Petersen et al.
C) Alzheimer's disease: Subjects with a MMSE score of 23 or lower who diagnosed with Alzheimer's disease by a dementia specialist based on one of the following items; ICD-10, DSM-5, and NIA-AA.
3) Subjects have no olfactory impairment who judged by a physician to be able to adequately describe their subjective symptoms and olfactory scores
4) Subjects who obtained written informed consent (informed consent from proxy for AD patients only).
Key exclusion criteria
Subjects who meet any of the exclusion criteria will not be enrolled in this study.
1) Subjects who have had an allergic reaction to a fragrance in the past.
2) Pregnant women or subjects who wish to become pregnant.
3) Subjects diagnosed with an olfactory disorder with a definite cause.
4) Subjects with epilepsy or who have a history of epilepsy.
5) Subjects with depression and other psychiatric disorders or who have a history of those.
6) Subjects who have taken a test such as MMSE or MoCA-J within one month of the date of obtaining consent.
7) Subjects who are expected to have a significant effect on the following olfactory functions.
- Subjects who reported smoking on the day of the olfactometry.
- Subjects who reported on the day of the olfactometry that they were concerned about olfactory dysfunction such as hay fever, rhinitis, or chronic sinusitis.
- Subjects who reported using the perfume on the day of the olfactometry.
- Subjects who reported consuming strongly smelling food from the day before to the day of the olfactometry.
8) Subjects who are bedridden or unconscious and determined to have severe Alzheimer's disease.
9) Current smoker.
10) Subjects who have been judged by the principal investigator or sub-investigator to be inappropriate for this study, in addition to the reasons listed above.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Business Development Section Household Division
Zip code
541-0045
Address
KDX Kobayashi-Doshomachi Building 10F, 4-4-10, Doshomachi, Chuo-ku, Osaka City, Osaka, Japan
TEL
070-1216-8047
t.fukumoto@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Mebix, Inc.
Division name
Research Promotion Group
Zip code
105-0001
Address
Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-4362-4504
Homepage URL
smell_cognitive@mebix.co.jp
Sponsor or person
Institute
Kobayashi Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
Institutional Review Board of Takahashi Clinic
Address
5-1-31 Iwayakita-machi, Nada-ku, Kobe City, Hyogo, Japan
Tel
078-882-6432
kishimoto.satoshi@neues.co.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 | 15 | 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
| 2020 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 04 | 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
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047698
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