UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060988 |
|---|---|
| Receipt number | R000069787 |
| Scientific Title | A Questionnaire Study on Subjective Satisfaction with Lecanemab Treatment and Its Contributing Factors Among Patients with Early Alzheimer's Disease and Their Family Care Partners |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/19 12:37:25 |
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Basic information
Public title
A Patient and Family Questionnaire Survey on Satisfaction with Lecanemab Treatment and Its Related Factors
Acronym
Survey on Satisfaction with Lecanemab Treatment
Scientific Title
A Questionnaire Study on Subjective Satisfaction with Lecanemab Treatment and Its Contributing Factors Among Patients with Early Alzheimer's Disease and Their Family Care Partners
Scientific Title:Acronym
Lecanemab Treatment Satisfaction and Factors Analysis Survey
Region
| Japan |
Condition
Condition
Early Alzheimer's Disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate subjective satisfaction with lecanemab treatment among patients with early Alzheimer's disease and their family care partners in real-world clinical practice, and to identify factors influencing treatment satisfaction.
Basic objectives2
Others
Basic objectives -Others
This is a non-interventional, cross-sectional questionnaire study conducted in real-world clinical practice to exploratorily assess treatment satisfaction and its associated factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment satisfaction among patients and their family care partners
Key secondary outcomes
Treatment understanding, treatment engagement, perceived treatment effects, other concerns (including aspects of the patient's daily functioning), and qualitative responses (free-text) among family care partners.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient
1)First-time respondent to this study questionnaire
2)Diagnosed with early AD and initiated lecanemab treatment
3)At least 6 months have passed since lecanemab treatment initiation
4)Written informed consent obtained based on the patient's free will
5)Age 18 years or older
Family care partner
1)First-time respondent to this study questionnaire
2)Provides daily support or caregiving to an eligible patient
3)Written informed consent obtained
4)Age 18 years or older
Key exclusion criteria
Patient
Unable to complete the questionnaire by themselves or via designated family assistance
Family care partner
Unable to complete the questionnaire
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hisayuki |
| Middle name | |
| Last name | Iwata |
Organization
Eisai Co., Ltd
Division name
Medical Headquarters, Neurology Department
Zip code
112-8088
Address
4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3817-3700
h3-iwata@hhc.eisai.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Endo |
Organization
Eisai Co., Ltd
Division name
Medical Headquarters, Neurology Department
Zip code
112-8088
Address
4-6-10 Koishikawa, Bunkyo-ku, Tokyo , Japan
TEL
03-3817-3700
Homepage URL
m4-endo@hhc.eisai.co.jp
Sponsor or person
Institute
Eisai Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihonbashi Sakura Clinic Institutional Review Board, Medical Corporation Oryokukai
Address
Inamura Building 5F, 1-9-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo 103-0025, Japan
Tel
03-6661-906
Non
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
該当なし（本研究は倫理指針下の非介入アンケート研究であり、医療機関は研究紹介のみを行う。文書同意・アンケート回収・データ加工は委託先にて実施し、医療機関は研究データの管理・取扱いおよび研究実施主体の役割を負わないため、試験実施施設の設定は行わない）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a non-interventional, cross-sectional questionnaire survey conducted in real-world clinical practice among patients treated with lecanemab and their family members.
Management information
Registered date
| 2026 | Year | 03 | Month | 19 | Day |
Last modified on
| 2026 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069787
