UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034643 |
|---|---|
| Receipt number | R000039495 |
| Scientific Title | Effects of tangram on cognitive function in patients with neurocognitive disorders |
| Date of disclosure of the study information | 2018/10/25 |
| Last modified on | 2025/04/30 10:06:08 |
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Basic information
Public title
Effects of tangram on cognitive function in patients with neurocognitive disorders
Acronym
Effects of tangram in patients with neurocognitive disorders
Scientific Title
Effects of tangram on cognitive function in patients with neurocognitive disorders
Scientific Title:Acronym
Effects of tangram in patients with neurocognitive disorders
Region
| Japan |
Condition
Condition
neurocognitive disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm effects of tangram on cognitive function in patients with neurocognitive disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Score of MMSE
Score of MoCa-J
Key secondary outcomes
NONE
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 observation period is 6 months.
The Tangram game treatment would be performed 30-40 minutes per time, 2-3 times per week. MMSE, MoCA-J test and TMT would be performed on the initial day and the end day.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatient diagnosed by neurocognitive disorders and get Mini-Mental state examination score between 17 to 30, age from 40 to 85 years old.
Outpatient who agree with this study by themselves.
Key exclusion criteria
Patient who disable to understand and agree this study.
Patient who have comorbidities with mental problems, particularly cognitive function be affected disease.
Patient with abuse of alcohol or psychoactive substance.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Narimasa |
| Middle name | |
| Last name | Katsuta |
Organization
Juntendo University
Division name
Psychiatry
Zip code
113-8421
Address
2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-5802-1071
nkatsuta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Narimasa |
| Middle name | |
| Last name | Katsuta |
Organization
Juntendo University
Division name
Psychiatry
Zip code
113-8421
Address
2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-5802-1071
Homepage URL
nkatsuta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Juntendo hospital IRB
Address
3-1-3 Hongo Bunkyo-ku Tokyo, Japan
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2018 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2673-5318/4/4/36
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2673-5318/4/4/36
Number of participants that the trial has enrolled
20
Results
20 participants were recruited, 3 participants dropped out from the study. No adverse events were noted. Statistically significant improvement was observed in MMSE total score (p = 0.016) and orientation segment (p = 0.026) in study 1. No statistically significant difference was noted in any of the segments in MMSE in study 2.
Results date posted
| 2025 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were diagnosed with mild AD or MCI with MMSE scores of 17-30 were recruited from the Department of Psychiatry, Juntendo University Hospital or Juntendo Tokyo Koto Geriatric Medical Center.
Participant flow
Following the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, AD was diagnosed based on clinical interviews with at least three experienced psychiatrists. Written informed consent was obtained from all participants. Patients who could not understand this research and those with psychiatric complications were excluded from the study. None of the participants had a history of alcoholism or psychoactive substance abuse. All participants were prescribed appropriately before enrolment and were required to maintain the dose regimen during the observation period.
Adverse events
No adverse events were noted.
Outcome measures
MMSE, Moca-J, TMT
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | 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
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039495
