UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059795 |
|---|---|
| Receipt number | R000068369 |
| Scientific Title | Effectiveness Evaluation of a Multifactorial Intervention Targeting Dementia Prevention Among Residents of Senior Housing |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/16 18:19:15 |
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Basic information
Public title
Effectiveness Evaluation of a Multifactorial Intervention Targeting Dementia Prevention Among Residents of Senior Housing
Acronym
Effectiveness Evaluation of a Multifactorial Intervention Targeting Dementia Prevention Among Residents of Senior Housing
Scientific Title
Effectiveness Evaluation of a Multifactorial Intervention Targeting Dementia Prevention Among Residents of Senior Housing
Scientific Title:Acronym
Effectiveness Evaluation of a Multifactorial Intervention Targeting Dementia Prevention Among Residents of Senior Housing
Region
| Japan |
Condition
Condition
Noraml Aged peiople
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Expand the multifactorial intervention "Cognicare", consisting of exercise/cognitive training and nutrition/health guidance, to participants in the preventive care and daily living support service program (residents of senior housing), and clarify its intervention effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preclinical Alzheimer's Disease without Clinical Symptoms at 2 Years Post-Intervention: Composite Cognitive Assessment (PACC)
(Mini-Mental State Examination (MMSE), Logical Memory Test, Free and Cued Selective Reminding Test, Digit Symbol Substitution Test)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognicare
Cognicare is a multifactorial intervention program for dementia prevention provided by the Center for Dementia Prevention Promotion, Graduate School of Health Sciences.
The program consists of: I. Dual-task exercise combining aerobic exercise with simultaneous cognitive training (e.g., performing hand/foot movements while doing calculations), II. Health seminars on dementia prevention (acquiring accurate knowledge), III. Health guidance based on cognitive function tests, questionnaires, and blood test results (providing a report showing current health status and future risks to encourage changes in health behaviors).
Interventions/Control_2
Control grope
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 60 or older residing in senior care facilities operated by HiMedic
2) Individuals certified as requiring support or eligible for preventive care/daily living support services (Basic Checklist)
3) Individuals able to personally agree to and sign the research consent form and Cognicare course terms and conditions
Key exclusion criteria
1) Individuals with injuries or illnesses that could affect their ability to participate in the exercise program
2) Individuals currently participating in other research studies or programs involving exercise
3) Individuals undergoing treatment for dementia or depression, or individuals deemed ineligible for study participation by their physician
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Research Center of Preventing Cognitive Disorder
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
TEL
078-796-4514
kowa@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University Graduate School of Health Sciences
Division name
Research Center of Preventing Cognitive Disorder
Zip code
654-1042
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
TEL
078-796-4514
Homepage URL
kowa@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Himedic, Inc.
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
Kobe University Health Sciences Ethics Committee
Address
7-10-2 Tomogaoka, Suma-ku Kobe 654-0142, Japan
Tel
078-796-4502
syomu2@ams.kobe-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
| 2025 | Year | 11 | Month | 17 | 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
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 16 | Day |
Last modified on
| 2025 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068369
