UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054968 |
|---|---|
| Receipt number | R000062548 |
| Scientific Title | A Study on the Efficacy of Synthetic MRI in Evaluating the Severity of Alzheimer's Disease, Anti-Amyloid Beta Treatment Effects , and Treatment-Related Complications |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2025/05/24 11:08:49 |
* 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
A Study on the Efficacy of Synthetic MRI in Evaluating the Severity of Alzheimer's Disease, Anti-Amyloid Beta Treatment Effects , and Treatment-Related Complications
Acronym
The evaluation of the treatment effects of Alzheimer's disease using Synthetic MRI
Scientific Title
A Study on the Efficacy of Synthetic MRI in Evaluating the Severity of Alzheimer's Disease, Anti-Amyloid Beta Treatment Effects , and Treatment-Related Complications
Scientific Title:Acronym
The evaluation of the treatment effects of Alzheimer's disease using Synthetic MRI
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate the therapeutic effects and risks of treatment-related complications in patients using lecanemab or donanemab compared to a control group not using the drug by analyzing various measurement data from MRI brain scans, including Synthetic MRI.Additionally, we will examine the utility of Synthetic MRI compared to conventional MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is to assess changes in brain volume over time by analyzing data from Synthetic MRI
Key secondary outcomes
The secondary outcome is to check whether ARIA develops, and examine the time to ARIA onset and its severity.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study enrolls patients over 20 years old diagnosed Alzheimer's disease according to the NIA-AA diagnostic criteria (2011).We assign patients who are eligible for receiving anti-Amyloid beta therapy, lecanemab or donanemab, and agree to continuous follow-up while receiving drug to the Anti-Amyloid Beta-treated group, and patients who are not eligible for receiving anti-amyloid beta treatment but agree to continuous follow-up to the non-Anti-Amyloid Beta-treated group.
Key exclusion criteria
We exclude patients in both groups who have contraindications for MRI imaging and are therefore unable to undergo continuous MRI imaging assessments, or are determined to be ineligible for this study by the principal investigator for any reason.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Sekijima |
Organization
Shinshu University Hospital
Division name
Neurology and Rheumatology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-2673
sannai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Morita |
Organization
Shinshu university Hospital
Division name
Neurology and Rheumatology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture
TEL
0263-37-2673
Homepage URL
yuki-m@shinhu-u.ac.jp
Sponsor or person
Institute
Shinshu university
Institute
Department
Personal name
Funding Source
Organization
non
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
Shinshu University School of Medicine Life Science and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto Cith, Nagano Prefecture
Tel
0263-37-2572
mdrinri@shinshu-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
| 2024 | Year | 07 | 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 | 03 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study design is a prospective observational study without intervention. We will enroll eligible participants who visit our hospital and agree to take part in this study, from the time when our study is approved by the ethics committee and the principal investigator allows it to proceed, until December 31, 2028. We will collect patient information (gender, age, height, body weight, comorbidities, past history, history of present illness, medications)and cognitive assessment scale results (MMSE-J), as well as MRI imaging (FLAIR, T2*WI, DWI, 3D T1WI, and each sequence of Synthetic MRI). Brain volume in 3D T1WI and Synthetic MRI is assessed and quantified using dedicated software for each technique, while other sequences are evaluated by radiologists. The total observation period is 18 months. In the Anti-Amyloid Beta-treated group, participants are evaluated at pre-treatment and 1, 2, 3, 6, 12, and 18 months after treatment initiation. In the non-Anti-Amyloid Beta-treated group, participants are evaluated at baseline and 6, 12, and 18 months after enrollment.
Management information
Registered date
| 2024 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062548
