UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056887 |
|---|---|
| Receipt number | R000065020 |
| Scientific Title | Exploring the efficacy and safety of brexpiprazole for behavioral and psychological symptoms of Alzheimer's disease in clinical settings |
| Date of disclosure of the study information | 2025/01/31 |
| Last modified on | 2025/02/05 06:59:37 |
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Basic information
Public title
Exploring the efficacy and safety of brexpiprazole for behavioral and psychological symptoms of Alzheimer's disease in clinical settings
Acronym
Exploring the efficacy and safety of brexpiprazole for behavioral and psychological symptoms of Alzheimer's disease in clinical settings
Scientific Title
Exploring the efficacy and safety of brexpiprazole for behavioral and psychological symptoms of Alzheimer's disease in clinical settings
Scientific Title:Acronym
Exploring the efficacy and safety of brexpiprazole for behavioral and psychological symptoms of Alzheimer's disease in clinical settings
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore whether brexpiprazole is effective at a lower dose and more comprehensively on the behavioral and psychological symptoms of Alzheimer's disease in clinical settings
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in NPI-Q total score before and after administration of brexpiprazole
Key secondary outcomes
Changes in NPI-Q subscores and CGI-S before and after brexpiprazole administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of brexpiprazole
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
| 55 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Meets the DSM-5 diagnostic criteria for Alzheimer's disease
2. MMSE score is 1-22
3. NPI-Q agitation/aggression score is 2 or higher
4. Takes Yokukansan or antipsychotics (CP equivalent: 200mg or less)
5. Concomitant use of anti-dementia drugs, sleeping pills, etc. is permitted under certain conditions
Key exclusion criteria
1, Comorbid dementia other than Alzheimer's disease.
2, Comorbid schizophrenia, mood disorder, anxiety disorder, drug/substance addiction, delirium, or personality disorder.
3, Serious physical illnesses such as cerebrovascular disease, renal dysfunction, and neurological disease.
4, The principal investigator or attending physician determines that the subject is unsuitable for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
3900921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
0262261311
a-tanaka@kuritahp.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
3800921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
0262261311
Homepage URL
a-tanaka@kuritahp.or.jp
Sponsor or person
Institute
Kurita hospital
Institute
Department
Personal name
Akira Tanaka
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurita hospital
Address
695 Kurita, Nagano City, Nagano Prefecture
Tel
0262261311
a-tanaka@kuritahp.or.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
| 2025 | Year | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065020
