UMIN-CTR Clinical Trial

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
Email	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
Email	smell_cognitive@mebix.co.jp

Sponsor
Institute	Kobayashi Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047698