UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055632 |
|---|---|
| Receipt number | R000063577 |
| Scientific Title | Study on Psychosocial Support for Patients Visiting the DMT Outpatient Clinic |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/09/26 14:20:55 |
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Basic information
Public title
Cognitive Impairment Experience Enriching Project
Acronym
CEEP
Scientific Title
Study on Psychosocial Support for Patients Visiting the DMT Outpatient Clinic
Scientific Title:Acronym
CEEP
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recanemab, a Disease Modifying Therapy (DMT) for mild cognitive impairment to mild dementia caused by Alzheimer's disease, has been launched. This observational study aims to obtain basic information for better support by conducting psychosocial assessment, including quality of life, in patients who visited the DMT outpatient clinic for eligibility assessment and administration of recanemab and other DMTs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EQ-5D-5L Japanese version, WHO-5 Mental Health Status Chart Simplified (WHO-5)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients and family members who visited our DMT outpatient clinic, underwent testing at the initial outpatient visit, and had the test results explained at the second outpatient visit.
Key exclusion criteria
Patients and family members whose participation is deemed undesirable by a team of psychiatrists and psychologists, based on their overall judgment, because it may impair their quality of life and physical health.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Matsui |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
department of psychiatry
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo
TEL
03-3964-1141
arara032@gmail.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Matsui |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
department of psychiatry
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
arara032@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo
Tel
03-3964-1141
arara032@gmail.com
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 | 09 | 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 | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients and their family members (including informal relatives and partners) who have been seen in the second outpatient visit of our DMT outpatient clinic are the subjects of this study. Patients with confirmed pathology and diagnosis of Alzheimer's disease who meet the guidelines for promoting optimal use of DMT administration and who wish to be administered DMT will be started on DMT. On the other hand, some patients do not receive DMT because they do not meet the guidelines. Data will be collected over a 12-month period for both the lecanemab-treated and non-recanemab-treated groups. Surveys using questionnaires (0, 6, and 12 months) will be conducted by mail, and interviews (3, 6, and 12 months) will be conducted in person or by telephone. In addition, they will be asked to keep a diary online (or a notebook paper diary if online is difficult). Finally, the survey will be combined with the information available from the medical records.
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063577
