UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055876 |
|---|---|
| Receipt number | R000063860 |
| Scientific Title | Web-based survey of physicians' perceptions and actual conditions of agitation associated with Alzheimer's disease. |
| Date of disclosure of the study information | 2024/10/18 |
| Last modified on | 2026/06/11 13:28:40 |
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Basic information
Public title
Web-based survey of physicians' perceptions and actual conditions of agitation associated with Alzheimer's disease.
Acronym
Survey of physicians' perceptions of Alzheimer's agitation.
Scientific Title
Web-based survey of physicians' perceptions and actual conditions of agitation associated with Alzheimer's disease.
Scientific Title:Acronym
Survey of physicians' perceptions of Alzheimer's agitation.
Region
| Japan |
Condition
Condition
Alzheimer's dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveying symptoms physicians recall as "agitation associated with Alzheimer's dementia".
Investigating the actual prescribing of antipsychotic drugs.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. physician background information
- Gender, age, department, number of beds, type of facility, physician's professional qualifications and affiliations
2. actual condition of AD patient care
-Number of AD patients and all patients in the last month, type of treatment for AD patients in the last month, medical coordination, names of drug classes and their ranking of newly prescribed drugs for AD patients, reasons for not newly prescribing antipsychotic drugs for AD patients (in Japanese).
3. recognition of BPSD
Recognition of BPSD rating scales and definitions, frequency of use of BPSD rating scales, frequency of BPSD occurrence in AD patients, types and ranking of BPSDs reported as difficult to cope with by caregivers of AD patients, BPSDs difficult to cope with and their ranking
4. recognition of AAD
Symptoms recalled by "agitation",number of patients with AAD treated in the last month
5. antipsychotic prescriptions
Frequency of prescribing for AAD, reasons for not prescribing for AAD, average duration of prescriptions, criteria for starting prescriptions, importance of prescribing and its ranking, side effects of concern and its ranking, prescribing policy when symptoms are stable, explanation to caregivers, evaluation of effectiveness of antipsychotic drugs, discontinuation Reasons for discontinuation
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
Psychiatrist, Neurologist, Neurosurgeon, General Physician
Physicians who have treated at least 10 AD patients in the last 1 month
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Shimizu |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Medical Affairs
Zip code
108-8241
Address
Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Shimizu.Kochi@otsuka.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Shimizu |
Organization
Otsuka Pharmaceutical Co.,Ltd.
Division name
Medical Affairs
Zip code
108-8241
Address
Shinagawa Grand Central Tower 2-16-4 Konan,Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Shimizu.Kochi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
Otsuka Pharmaceutical Co., Ltd. Research Division Research Ethics Committee
Address
463-10 Kagasuno, Kawauchi-cho, Tokushima City, Tokushima Prefecture
Tel
088-665-2126
Suzuki.Takashi@otsuka.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 | 10 | Month | 18 | Day |
Related information
URL releasing protocol
https://doi.org/10.1038/s41598-026-51118-5
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1038/s41598-026-51118-5
Number of participants that the trial has enrolled
529
Results
Among 529 physicians, differences were observed across specialties in the recognition and treatment of agitation associated with Alzheimer's dementia (AAD). AAD accounted for approximately 24 percent of AD patients. Antipsychotic prescribing was highest in psychiatry and lower in other specialties. Limited awareness was noted in general internal medicine, indicating variability across specialties.
Results date posted
| 2026 | Year | 06 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 529 physicians were included in the analysis: psychiatry (40.1%), general internal medicine (29.7%), neurology (19.5%), and neurosurgery (10.8%). Male physicians accounted for 89.2% of participants. The most common age group was in the 50s (27.2%). The majority worked in general hospitals (52.2%), followed by clinics (26.5%).
Participant flow
A total of 3,560 physicians were invited. Of these, 576 provided consent and proceeded to screening. Among them, 533 met the eligibility criteria and completed the survey. After quality control, 4 participants were excluded, resulting in 529 physicians included in the final analysis.
Adverse events
No adverse events or safety data were collected in this study.
Outcome measures
Primary outcomes included physician background characteristics, clinical practice related to AD patients, recognition and use of BPSD assessment tools, perception of AAD, and prescribing patterns of antipsychotic medications (frequency, reasons for non-prescribing, duration, initiation criteria, and safety concerns).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Surveying symptoms physicians recall as "agitation associated with Alzheimer's dementia"
Investigating the actual prescribing of antipsychotic drugs
Management information
Registered date
| 2024 | Year | 10 | Month | 18 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063860
