UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046172 |
|---|---|
| Receipt number | R000052539 |
| Scientific Title | Effects of "kanji" training on patients with mild cognitive impairment and mild dementia: a randomized controlled trial |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/11/27 14:29:44 |
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Basic information
Public title
A study about the effect of "kanji" training on cognitive function
Acronym
KKP-CT
Scientific Title
Effects of "kanji" training on patients with mild cognitive impairment and mild dementia: a randomized controlled trial
Scientific Title:Acronym
KKP-CT
Region
| Japan |
Condition
Condition
mild cognitive impairment, mild dementia
Classification by specialty
| Neurology | Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of "kanji" training to maintain cognitive function of patients with mild cognitive impairment and mild dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MMSE-J score(before, immediately after and 6-months after the cognitive training)
Key secondary outcomes
1. ADAS (Alzheimer's Disease Assessment Scale) score
2. the score of Logical Memory Test from WMS-R (Wecheler Memory Scale Revised)
3. the score of Block Design from WAIS-IV (Wechsler Adult Intelligence Scale-4th edition)
4. TMT-J (Trail Making Test-Japanese) score
5. WF (verbal fluency test) score
6. JART (Japanese Adult Reading Test) score
7. DEMQOL, the assessment health-related quality of life, score
8. the achievement rate and accuracy of "kanji" training
9. the Questionnaire about the habit of "kanji" training
10. the questionnaire about writing habit
11. the score of 20 questions of "kanji"
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
"kanji" training: to voluntarily work on the "kanji" assignments given every two months for 6 months independently
Interventions/Control_2
control without any interventions
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
| 50 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) The patients with persistent cognitive decline detected by themselves or family members.
2) The patients diagnosed by neurologist as mild cognitive impairment (MCI) or dementia in the early stage.
3) the dose and usage of dementia medications are stable for at least 12 weeks before the participation
4) the mother language is Japanese
Key exclusion criteria
1) the patients with a moderate or severe psychiatric disease such as depression
2) the patients with difficulty in psychological test or "kanji" training, for example with visual or hearing impairment or language disorders.
3) the patients with difficulty in the participation by comorbid medical diseases.
4) The patients with a brain organic lesions or significant abnormal findings in the blood tests.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kuzuya |
Organization
Kyoto University Hospital
Division name
Department of Neurology
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513771
akuzuya@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiho |
| Middle name | |
| Last name | Ueda |
Organization
Kyoto University Hospital
Division name
Department of Neurology
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3460
Homepage URL
sakiho@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Kyoto University
Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Japan Kanji Aptitude Testing Foundation (Nihon Kanji Noryoku Kentei Kyokai)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
clinical trial inquiry- Kyoto University Hospital
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-751-4748
ctsodan@kuhp.kyoto-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
京都大学医学部附属病院/Kyoto University Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
29 out of 100 target cases were enrolled. Three of the enrolled cases were discontinued before the end of observation.
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052539
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
