UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060451 |
|---|---|
| Receipt number | R000069167 |
| Scientific Title | A Longitudinal Observational Study Investigating the Association Between Amyloid Pathology and Electroencephalographic Findings |
| Date of disclosure of the study information | 2026/01/23 |
| Last modified on | 2026/01/23 16:49:45 |
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Basic information
Public title
A Longitudinal Observational Study Investigating the Association Between Amyloid Pathology and Electroencephalographic Findings
Acronym
Amyloid-EEG Longitudinal Study
Scientific Title
A Longitudinal Observational Study Investigating the Association Between Amyloid Pathology and Electroencephalographic Findings
Scientific Title:Acronym
Amyloid-EEG Longitudinal Study
Region
| Japan |
Condition
Condition
Patients who are considered, based on the treating physician's clinical judgment, to be potentially eligible for anti-amyloid beta antibody therapy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the association between amyloid pathology and electroencephalographic characteristics.
Basic objectives2
Others
Basic objectives -Others
To exploratorily investigate the association between longitudinal changes in amyloid pathology, electroencephalographic characteristics, and clinical symptoms over the clinical course, including the presence or absence of treatment with anti-amyloid beta antibody therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To exploratorily assess the association between electroencephalographic characteristics and clinical information obtained from routine clinical practice related to anti-amyloid beta antibody therapy.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are considered, based on the treating physician's clinical judgment, to be potentially eligible for anti-amyloid beta antibody therapy
Key exclusion criteria
Patients who are judged by the treating physician to be inappropriate for participation in this study, based on the patient's clinical condition and the purpose of the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Kishima |
Organization
the University of Osaka
Division name
Department of Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
0668793051
mhata@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hata |
Organization
the University of Osaka
Division name
Department of Psychiatry
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
0668793051
Homepage URL
mhata@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
the University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Osaka University Hospital
Address
2-2, Yamadaoka, Suita, osaka, japan
Tel
0662108296
rinri@hp-crc.med.osaka-u.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 | 01 | Month | 23 | 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 | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study that longitudinally collects clinical information obtained during routine clinical care, amyloid-related test results, and electroencephalographic findings, and explores their associations.
Management information
Registered date
| 2026 | Year | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069167
