UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058620 |
|---|---|
| Receipt number | R000067030 |
| Scientific Title | Age-related changes and the impact of early Alzheimer's disease on spatial comprehension |
| Date of disclosure of the study information | 2025/10/10 |
| Last modified on | 2025/07/28 20:15:22 |
* 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
Age-related changes and the impact of early Alzheimer's disease on spatial comprehension
Acronym
Age-related changes and the impact of early Alzheimer's disease on spatial comprehension
Scientific Title
Age-related changes and the impact of early Alzheimer's disease on spatial comprehension
Scientific Title:Acronym
Age-related changes and the impact of early Alzheimer's disease on spatial comprehension
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the usefulness of spatial comprehension tasks by applying them to older adults and individuals with early-stage Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of correct responses on the spatial comprehension task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The spatial comprehension task was administered. Sentences involving human relationships (e.g., uncle-nephew) were excluded, as they were expected to be influenced by generational differences. Similarly, spatial relations (e.g., "the triangle is to the right of the circle and to the left of the square") were excluded due to the anticipated influence of visuospatial processing.
The task was based on Urano et al. (2011) and consisted of 30 sentences involving relational understanding: 12 temporal relation items, 12 two-element comparison items, and 6 three-element comparison items. For each item type, half of the sentences included word order transformation and/or reference point transformation. All items were presented in a randomized order.
As a control condition, an additional 30 sentences without relational content were created, matched in structure to include or exclude word order and reference point transformations in the same manner.
Interventions/Control_2
The spatial comprehension task was administered. Sentences involving human relationships (e.g., uncle-nephew) were excluded, as they were expected to be influenced by generational differences. Similarly, spatial relations (e.g., "the triangle is to the right of the circle and to the left of the square") were excluded due to the anticipated influence of visuospatial processing.
The task was based on Urano et al. (2011) and consisted of 30 sentences involving relational understanding: 12 temporal relation items, 12 two-element comparison items, and 6 three-element comparison items. For each item type, half of the sentences included word order transformation and/or reference point transformation. All items were presented in a randomized order.
As a control condition, an additional 30 sentences without relational content were created, matched in structure to include or exclude word order and reference point transformations in the same manner.
Interventions/Control_3
The spatial comprehension task was administered. Sentences involving human relationships (e.g., uncle-nephew) were excluded, as they were expected to be influenced by generational differences. Similarly, spatial relations (e.g., "the triangle is to the right of the circle and to the left of the square") were excluded due to the anticipated influence of visuospatial processing.
The task was based on Urano et al. (2011) and consisted of 30 sentences involving relational understanding: 12 temporal relation items, 12 two-element comparison items, and 6 three-element comparison items. For each item type, half of the sentences included word order transformation and/or reference point transformation. All items were presented in a randomized order.
As a control condition, an additional 30 sentences without relational content were created, matched in structure to include or exclude word order and reference point transformations in the same manner.
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
| 20 | years-old | < |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who provided informed consent
2.Individuals whose age falls within the designated range for each age group; for the AD group, participants were within one year of diagnosis
3.Individuals without a predisposition for left-handedness, as determined by the Edinburgh Handedness Inventory
Key exclusion criteria
Individuals with a large amount of missing data in the collected dataset
Target sample size
153
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Omori |
Organization
International University of Health and Welfare
Division name
Department of Speech and Hearing Sciences School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City Chiba
TEL
0476207793
tomohiroomori@ihwg.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Omori |
Organization
International University of Health and Welfare
Division name
Department of Speech and Hearing Sciences School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita City Chiba
TEL
0476207793
Homepage URL
tomohiroomori@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3 Kozunomori, Narita City Chiba
Tel
0476207793
tomohiroomori@ihwg.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
千葉県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 10 | 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 | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067030
