UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055333 |
|---|---|
| Receipt number | R000063236 |
| Scientific Title | Development of imaging methods that contribute to the elucidation of the pathological mechanism of amyloid-related imaging abnormalities and the safety monitoring |
| Date of disclosure of the study information | 2024/08/26 |
| Last modified on | 2024/08/26 00:44:39 |
* 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
Development of imaging methods that contribute to the elucidation of the pathological mechanism of amyloid-related imaging abnormalities and the safety monitoring
Acronym
Development of imaging methods that contribute to the elucidation of the pathological mechanism of amyloid-related imaging abnormalities and the safety monitoring
Scientific Title
Development of imaging methods that contribute to the elucidation of the pathological mechanism of amyloid-related imaging abnormalities and the safety monitoring
Scientific Title:Acronym
Development of imaging methods that contribute to the elucidation of the pathological mechanism of amyloid-related imaging abnormalities and the safety monitoring
Region
| Japan | North America |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed 1) to exploratively investigate longitudinal changes in the BBB water exchange rate as the kw index and magnetic susceptibility values divided into the para- and diamagnetism, 2) to demonstrate whether these changes could be used to predict the onset of ARIA, and 3) to ascertain the associations between these quantitative metrics and cognitive changes during the administration of anti-Abeta therapies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations between cognitive function tests and imaging biomarkers (BBB water exchange rate as kw index, paramagnetism, diamagnetism)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study participants comprised consecutive patients to whom anti-Abeta monoclonal antibodies were administered between May 2024 and October 2024. The diagnosis and clinical staging for individuals on the Alzheimer disease continuum were made based on the Alzheimer Association Workgroup. The patients who agreed to participate in this study were scanned with DP-pCASL and multiple spoiled gradient echo sequences for the evaluation of ARIA pathomechanisms in addition to conventional MRI sequences, including T2-weighted image and FLAIR, for the ARIA diagnosis.
Key exclusion criteria
Patients who cannot be administered Abeta monoclonal antibodies or who did not consent to testing.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
052-853-8094
uchidayuto0720@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Uchida |
Organization
Nagoya City University
Division name
Neurology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-ku, Nagoya
TEL
052-853-8094
Homepage URL
uchidayuto0720@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
KAKEN
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
Institutional Review Board of Toyokawa City Hospital
Address
23 Noji, Yawata-cho, Toyokawa, Aichi
Tel
0533-86-1111
tch@toyokawa-ch-aichi.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 | 08 | Month | 26 | 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 | 01 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.A.
Management information
Registered date
| 2024 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063236
