UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046172
Receipt No. 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 2021/11/25

* 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 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
Email 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
Email sakiho@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Neurology, Kyoto University
Graduate School of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 01 Day
Date of IRB
2021 Year 10 Month 29 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2023 Year 10 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
2021 Year 11 Month 25 Day
Last modified on
2021 Year 11 Month 25 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


Contact us.