UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053721 |
|---|---|
| Receipt number | R000061259 |
| Scientific Title | Economic effects simulation based on a questionnaire survey of Alzheimer's disease test in adults |
| Date of disclosure of the study information | 2024/03/08 |
| Last modified on | 2025/09/29 10:21:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey study on Alzheimer's disease in adults
Acronym
Survey study on Alzheimer's disease in adults
Scientific Title
Economic effects simulation based on a questionnaire survey of Alzheimer's disease test in adults
Scientific Title:Acronym
Economic effects simulation based on a questionnaire survey of Alzheimer's disease test in adults
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, simulations to estimate the number of tests, number of patients, and average access waiting time when blood-based biomarker tests were incorporated into medical treatment compared to existing tests for Alzheimer's disease, based on information from a questionnaire survey.
Basic objectives2
Others
Basic objectives -Others
Economic evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of tests, number of patients, and average access waiting time simulated from a questionnaire survey information
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study is a simulation based on publicly known information and information from a questionnaire survey within this study, and there are no standards for subjects or eligibility.
The selection criteria for the questionnaire survey are as follows.
1. Those who agree to participate in the research of their own free will
2. Those who are 18 years of age or older at the time of obtaining consent
3. Those who can personally respond to a web-based survey
Key exclusion criteria
This study is a simulation based on publicly known information and information from a questionnaire survey within this study, and there are no standards for subjects or eligibility.
The exclusion criteria for the questionnaire survey are as follows.
1. Those who have been diagnosed with dementia (cerebrovascular, Alzheimer's type, etc.) or mild cognitive impairment (MCI) in the past.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kimura |
Organization
Oita University
Division name
Department of Neurology, Faculty of Medicine Oita University
Zip code
879-5593
Address
1-1, Idaigaoka, Hasama-mach, Yufu, Oita 879-5593, Japan
TEL
097(586)5814
noriyuki@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Temmei |
| Middle name | |
| Last name | Ito |
Organization
Eisai Co., Ltd.
Division name
Global AD
Zip code
112-8088
Address
4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan
TEL
070-2468-2164
Homepage URL
t13-ito@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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Eisai Research Ethics Review Committee
Address
5-1-3 Tokodai, Tsukuba, Ibaraki 300-2635
Tel
+81-70-2474-2971
m-kogushi@hhc.eisai.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
| 2024 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://alz.confex.com/alz/2025/meetingapp.cgi/Paper/102553
Number of participants that the trial has enrolled
3302
Results
Based on the results of simulations derived from the questionnaire survey, under the current diagnostic flow, the number of individuals diagnosed as positive by general practitioners based on cognitive assessment and subsequently visiting specialists was estimated to be 980,218. The maximum mean wait time for specialist consultation was estimated to be 6.4 months. The estimated number of treatment-eligible patients by year was 14,554 in 2023 (from December 20), 183,376 in 2024, and 32,301 in 2025.
Results date posted
| 2025 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the 3,302 respondents to the questionnaire survey, the distribution by gender and age group was as follows: For men, 20.0% were aged 50-59, 18.5% were aged 60-69, and 10.5% were aged 70-74. For women, 20.0% were aged 50-59, 19.3% were aged 60-69, and 11.6% were aged 70-74.
Participant flow
The survey participants were randomly selected from the research company's panel. Questionnaires were distributed to eligible panel members based on inclusion and exclusion criteria, and responses were collected from each demographic group until the target number for each group was reached.
Adverse events
N/A
Outcome measures
The number of patients visiting specialists for testing, the average wait time, and the number of treatment-eligible patients, estimated by simulations using questionnaire data.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, simulations to estimate the number of tests, number of patients, and average access waiting time when blood-based biomarker tests were incorporated into medical treatment compared to existing tests for Alzheimer's disease, based on information from a questionnaire survey.
The items of the survey include the amount of copayments for tests, types of tests, waiting time, and side effects. The target population will be registered members of the general panel (18-74 years old).
Management information
Registered date
| 2024 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061259
