UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060413 |
|---|---|
| Receipt number | R000069110 |
| Scientific Title | Biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy in early Alzheimer's disease: a multicenter prospective observational study |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/20 16:48:01 |
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Basic information
Public title
Biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy in early Alzheimer's disease: a multicenter prospective observational study
Acronym
ATT decision-making study
Scientific Title
Biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy in early Alzheimer's disease: a multicenter prospective observational study
Scientific Title:Acronym
ATT decision-making study
Region
| Japan |
Condition
Condition
Early Alzheimer's disease (MCI due to AD / mild AD dementia)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify biopsychosocial factors associated with treatment decision-making in patients initiating anti-amyloid beta antibody therapy (lecanemab or donanemab), and to examine longitudinal changes in decision-making capacity over 18 months.
Basic objectives2
Others
Basic objectives -Others
To explore additional biopsychosocial factors that may influence treatment decision-making, including demographic, neuropsychological, behavioral, and social variables.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
MacCATT total score and its association with clinical variables (cognitive function, neuropsychiatric symptoms, psychological loneliness, ADL, MRI findings, amyloid PET findings).
Key secondary outcomes
Associations between MacCATT subscale scores and amyloid PET parameters (SUVR, composite SUVR, centiloid, asymmetry index).
Longitudinal changes in treatment decision-making capacity at 6, 12, and 18 months and their associations with clinical variables.
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients clinically diagnosed with probable Alzheimer's disease dementia or MCI due to Alzheimer's disease at participating institutions between the ethics approval date and March 31, 2027.
Patients who underwent amyloid PET and were confirmed positive.
Patients for whom intravenous treatment with lecanemab or donanemab has been determined to be appropriate by the attending physician.
Patients who have provided written informed consent, either directly or via a legally authorized representative.
Age between 50 and 90 years.
Key exclusion criteria
- Patients whose amyloid PET result was negative at the baseline evaluation
- Patients diagnosed with mild cognitive impairment or dementia due to other neurodegenerative diseases or medical conditions
- Patients deemed unsuitable for participation in this study by the attending physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kasanuki |
Organization
St. Marianna Universitiy School of Medicine
Division name
Department of Neuropsychiatry
Zip code
216-8511
Address
2-16-1, Miyamae-Ku, Kawasaki city, Kanagawa Prefecture
TEL
0449778111
koji.kasanuki@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kasanuki |
Organization
St. Marianna Universitiy School of Medicine
Division name
Department of Neuropsychiatry
Zip code
216-8511
Address
2-16-1, Miyamae-Ku, Kawasaki city, Kanagawa Prefecture
TEL
0449778111
Homepage URL
koji.kasanuki@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Koji Kasanuki
Funding Source
Organization
Nihon Medi-Physics Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, St. Marianna University School of Medicine (Clinical Trial Subcommittee)
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa 216-8511, Japan
Tel
0449778111
doppy@marianna-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
聖マリアンナ医科大学 神経精神科学（神奈川県）、京都府立医科大学 精神機能病態学（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a multi-institutional observational study exploring biopsychosocial factors associated with treatment decision-making for anti-amyloid beta antibody therapy. Participants are elderly individuals at participating institutions who are being considered for such therapy, and assessments are conducted prior to treatment initiation. Case registration will be conducted at St. Marianna University School of Medicine and Kyoto Prefectural University of Medicine. Maizuru Medical Center will contribute data collection only. The study is scheduled to begin in January 2026, with the registration period planned until March 2027.
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069110
