UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060468 |
|---|---|
| Receipt number | R000069181 |
| Scientific Title | Establishing Subtype Classification and Support Models Based on Pre-Diagnostic Clinical Evaluation in Elderly Patients with Cognitive Impairment as the Primary Complaint |
| Date of disclosure of the study information | 2026/01/26 |
| Last modified on | 2026/01/26 11:51:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Characteristics and Support for Patients Complaining of Cognitive Impairment
Acronym
A Study on the Characteristics and Support for Patients Complaining of Cognitive Impairment
Scientific Title
Establishing Subtype Classification and Support Models Based on Pre-Diagnostic Clinical Evaluation in Elderly Patients with Cognitive Impairment as the Primary Complaint
Scientific Title:Acronym
Establishing Subtype Classification and Support Models Based on Pre-Diagnostic Clinical Evaluation in Elderly Patients with Cognitive Impairment as the Primary Complaint
Region
| Japan |
Condition
Condition
Patients who visited the outpatient clinic with cognitive decline as their primary complaint
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to identify subtypes based on the results of neuropsychological tests used in clinical practice among elderly patients presenting with cognitive decline as their primary complaint, and to clarify the characteristics of these subtypes.
Basic objectives2
Others
Basic objectives -Others
Identification of subtypes based on neuropsychological test results
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Version Montoreal Cognitive Assessment
Key secondary outcomes
FAB
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals with a Montreal Cognitive Assessment score of 18 or higher
First-time patients
Key exclusion criteria
Individuals with other clearly defined neurological disorders that cause cognitive impairment
Individuals with mental disorders that affect their ability to understand test instructions or perform tasks
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Daigo |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
daigo.0612@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
daigo.0612@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Human Subjects Committee of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
0334331111
rinri@jikei.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
東京慈恵会医科大学葛飾医療センター（東京）/The Jikei University Katsushika Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is currently collecting data.
Management information
Registered date
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069181
