UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061264 |
|---|---|
| Receipt number | R000069873 |
| Scientific Title | A Study on Treatment Preferences Regarding Dosage Forms of Dementia Medications in Japan. |
| Date of disclosure of the study information | 2026/04/16 |
| Last modified on | 2026/04/15 09:32:26 |
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Basic information
Public title
A Study on Treatment Preferences Regarding Dosage Forms of Dementia Medications in Japan.
Acronym
A Study on Treatment Preferences Regarding Dosage Forms of Dementia Medications in Japan.
Scientific Title
A Study on Treatment Preferences Regarding Dosage Forms of Dementia Medications in Japan.
Scientific Title:Acronym
A Study on Treatment Preferences Regarding Dosage Forms of Dementia Medications in Japan.
Region
| Japan |
Condition
Condition
MCI due to Alzheimer's disease (AD) or Mild AD dementia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to quantify the factors and preferences influencing treatment selection for mild cognitive impairment and mild dementia due to Alzheimer's disease, expressed as utility values derived from the value judgments of the general population.
Basic objectives2
Others
Basic objectives -Others
Treatment Preferences Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Utility values represent the factors and preferences underlying treatment selection for mild cognitive impairment and mild dementia due to Alzheimer's disease in the general population.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following conditions to be eligible for inclusion in the study:
1. Aged 40 years or older and younger than 80 years at the time of enrollment.
2. Provides informed consent to participate in the study.
3. Resides in Japan at the time of enrollment.
4. Has access to the necessary devices and a stable internet environment to complete the study online.
Key exclusion criteria
Participants who meet any of the following conditions will be excluded from the study:
1. Individuals for whom obtaining informed consent or completing the study procedures is deemed difficult due to insufficient comprehension ability, cognitive capacity, or Japanese language proficiency.
2. Individuals who are unable to personally participate in the survey.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kiyoyuki |
| Middle name | |
| Last name | Tomita |
Organization
Eisai Co., Ltd.
Division name
Japan Value and Access Department
Zip code
112-8088
Address
Koishikawa 4-6-10, Bunkyo-ku, Tokyo, 112-8088, Japan
TEL
080-2158-5462
k2-tomita@hhc.eisai.co.jp
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Azuma |
Organization
Eisai Co., Ltd.
Division name
Japan Value and Access Department
Zip code
112-8088
Address
Koishikawa 4-6-10, Bunkyo-ku, Tokyo, 112-8088, Japan
TEL
070-2474-2454
Homepage URL
m3-azuma@hhc.eisai.co.jp
Sponsor or person
Institute
Eisai Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic IRB
Address
Daiwa A Hamamatsu-chiyou building, 6 floor, 1-9-10 Hamamatsu-chiyou, Minato-ku, 105-0013 Tokyo
Tel
03-5408-1555
rinri@s-palace-clinic.com
Secondary IDs
Secondary IDs
YES
Study ID_1
R2000-J081-016
Org. issuing International ID_1
Eisai Co., Ltd.
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 16 | 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
| 2026 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is classified, in accordance with the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects, as a non-invasive, non-interventional research study that does not use human-derived biological specimens, and is conducted as an online questionnaire survey targeting members of the general public.
The survey will be carried out via the internet between April and May 2026.
To evaluate treatment-related attributes and preferences, the study employs a Discrete Choice Experiment (DCE) method, which enables quantitative estimation of respondents' latent preferences.
Management information
Registered date
| 2026 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069873
