UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063563 |
|---|---|
| Receipt number | R000072740 |
| Scientific Title | Early cognitive intervention on executive function and working memory in mild cognitive impairment due to Alzheimer's disease |
| Date of disclosure of the study information | 2026/11/09 |
| Last modified on | 2026/11/09 10:04:22 |
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Basic information
Public title
Early cognitive intervention on executive function and working memory in mild cognitive impairment due to Alzheimer's disease
Acronym
Single-group pre- and postintervention study
Scientific Title
Early cognitive intervention on executive function and working memory in mild cognitive impairment due to Alzheimer's disease
Scientific Title:Acronym
Single-group pre- and postintervention study
Region
| Japan |
Condition
Condition
Mild cognitive impairment (MCI) due to Alzheimer's disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of an early cognitive intervention designed to enhance executive function and working memory in older adults with mild cognitive impairment (MCI) due to Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral Assessment of Dysexecutive Syndrome (BADS) and Trail Making Test (TMT) scores before and after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The early cognitive intervention comprised an executive function task and a working memory task.
Each 90-minute session consisted of two 45-minute tasks and was conducted once weekly for 12 weeks in groups of approximately five participants.
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Older adults with MCI due to Alzheimer's disease are recruited from a psychiatric hospital. MCI due to Alzheimer's disease is diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR)
Key exclusion criteria
(a) absence of vascular lesions
(b) absence of other types of MCI (such as MCI due to Lewy body disease or frontotemporal degeneration) and mental disorders (such as schizophrenia or major depressive disorder) that could cause cognitive deficits
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Fukuta |
Organization
Nippon Medical School
Division name
Faculty of Medical Care and Health Sciences
Zip code
211-8602
Address
1-383 Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa, Japan
TEL
044-455-5461
d-fukuta@nms.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Fukuta |
Organization
Nippon Medical School
Division name
Faculty of Medical Care and Health Sciences
Zip code
211-8602
Address
1-383 Kosugimachi, Nakahara-ku, Kawasaki, Kanagawa, Japan
TEL
044-455-5461
Homepage URL
d-fukuta@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
The Institutional Review Board of Tokiwa University
Address
1-430-1 Miwa, Mito, Ibaraki 310-8585, Japan
Tel
029-232-2511
d-fukuta@nms.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
| 2026 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
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 | 11 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 11 | Month | 09 | Day |
Last modified on
| 2026 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072740
