UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054281 |
|---|---|
| Receipt number | R000061987 |
| Scientific Title | A study of changes in treatment satisfaction and its factors in patients treated with lecanemab |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/11/18 12:30:12 |
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Basic information
Public title
A study of changes in treatment satisfaction and its factors in patients treated with lecanemab
Acronym
A study of treatment satisfaction in lecanemab-treated patients
Scientific Title
A study of changes in treatment satisfaction and its factors in patients treated with lecanemab
Scientific Title:Acronym
A study of treatment satisfaction in lecanemab-treated patients
Region
| Japan |
Condition
Condition
early Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess longitudinal treatment satisfaction and identify factors associated with changes in treatment satisfaction with lecanemab, the first disease-modifying drug for Alzheimer's disease to be approved in Japan
Basic objectives2
Others
Basic objectives -Others
treatment satisfaction
This study aims to evaluate the longitudinal changes in treatment satisfaction (TSQM) over a three-year period beginning six months after the initiation of lecanemab therapy, using linear mixed-effects models.
Given the potential for treatment satisfaction to decline over time due to disease progression and the burden of ongoing infusions and assessments, as well as the possibility that satisfaction may be maintained or even increase as patients perceive the long-term benefits of a disease-modifying therapy, we do not presuppose a specific direction of change.
Accordingly, the primary objective is to estimate the presence or absence of a time effect on TSQM, along with the magnitude and 95% confidence intervals of these longitudinal changes, to clarify the actual trajectory of treatment satisfaction in real-world clinical practice.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment Satisfaction Questionnaire for Medication (TSQM) score
Key secondary outcomes
Neuropsychiatric Inventory Questionnaire(NPI-Q) score, Everyday memory checklist(EMC) score, the presence of Amyloid Related Imaging Abnormalities(ARIA)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with probable/possible AD dementia or MCI due to AD-intermediate/high likelihood according to the 2011 NIA-AA clinical criteria.
2) Patients with a positive amyloid PET or cerebrospinal fluid (CSF) Ab42/40 ratio.
3) Patients who will receive lecanemab (consent can be obtained up to 26 weeks after administration even if the drug has been administered).
4) Patients who are at least aged 40 and less than 90 at the time of obtaining consent.
5) Individuals whose written consent to participate in the study has been obtained from them.
Patients who meet the above criteria and their carers will be included.
Key exclusion criteria
1) Persons with uncontrolled physical illnesses.
2) Persons who have another nationality or speak a language other than Japanese as their mother tongue.
Patients who meet the above criteria and their carers are excluded from the eligible participants.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-871
Address
D3 2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3051
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Satake |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
565-871
Address
D3 2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3051
Homepage URL
y.satake@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
1-1 Yamadaoka, Suita, Osaka, Japan
Tel
06-6877-5111
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
| 2024 | Year | 05 | Month | 01 | 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
74
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data including patient satisfaction will be collected at 6 months, 1 year, 1.5 years, 2 years and 3 years after the start of recanemab treatment; all MRI imaging data obtained during the 3-year follow-up will be collected. Patients within six months of receiving RECANEMAB will be eligible for recruitment.
Management information
Registered date
| 2024 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061987
