UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062108 |
|---|---|
| Receipt number | R000071025 |
| Scientific Title | A prospective observational study to develop prediction models for prognosis and adverse events during anti-amyloid antibody therapy in patients with Alzheimer's disease |
| Date of disclosure of the study information | 2026/07/10 |
| Last modified on | 2026/07/01 19:41:00 |
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Basic information
Public title
Development of a prognostic prediction model for anti-amyloid antibody therapy in Alzheimer's disease
Acronym
HiRAPAR study
Scientific Title
A prospective observational study to develop prediction models for prognosis and adverse events during anti-amyloid antibody therapy in patients with Alzheimer's disease
Scientific Title:Acronym
HiRAPAR study
Region
| Japan |
Condition
Condition
Mild cognitive impairment, dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to prospectively enroll patients with Alzheimer's disease or suspected Alzheimer's disease who are considered for initiation, discontinuation, or resumption of anti-amyloid antibody therapy at Kansai Medical University Hospital and Kansai Medical University Medical Center. The study will evaluate prognosis, adverse events including amyloid-related imaging abnormalities, behavioral and psychological symptoms, cognitive function, and physical function, with the aim of developing prediction models for clinical outcomes and adverse events.
Basic objectives2
Others
Basic objectives -Others
To develop prediction models for clinical outcomes and adverse events, including amyloid-related imaging abnormalities, after anti-amyloid antibody therapy using clinical data, neuroimaging findings, blood and cerebrospinal fluid biomarkers, and APOE genotype in patients with mild cognitive impairment or mild Alzheimer's disease who are considered for initiation, discontinuation, or resumption of anti-amyloid antibody therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of amyloid-related imaging abnormalities and behavioral and psychological symptoms of dementia according to baseline MRI findings.
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
1) Patients with suspected mild cognitive impairment or mild Alzheimer's disease who are considered for initiation or discontinuation of anti-amyloid antibody therapy.
2) No age restriction.
3) Both outpatients and inpatients are eligible.
4) Both sexes are eligible.
5) Patients who provide written informed consent after receiving sufficient explanation. If the patient is unable to provide valid consent due to cognitive impairment, written consent may be obtained from a legally acceptable representative.
Key exclusion criteria
1) Patients for whom written consent cannot be obtained from the patient or family member/representative.
2) Patients judged by the principal investigator to be inappropriate for participation in the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Yakushiji |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
573-1010
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
0728040101
yakushiji.yus@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Doyama |
Organization
Kansai Medical University
Division name
Department of Neurology
Zip code
5731010
Address
2-5-1 Shinmachi, Hirakata, Osaka
TEL
0728040101
Homepage URL
doyama.tat@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
Ethics Committee of Kansai Medical University
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
072-804-0101
rinri@kmu.ac.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
| 2026 | Year | 07 | Month | 10 | 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 | 05 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient enrollment has started after approval by the ethics committee and permission from the head of the research institution. Enrollment is currently ongoing at Kansai Medical University Hospital and Kansai Medical University Medical Center among patients who are considered for initiation, discontinuation, or resumption of anti-amyloid antibody therapy. The study is progressing smoothly in accordance with the study protocol.
Management information
Registered date
| 2026 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071025
