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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034643
Receipt No. R000039495
Scientific Title Effects of tangram on cognitive function in patients with Alzheimer's disease
Date of disclosure of the study information 2018/10/25
Last modified on 2018/10/25

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Basic information
Public title Effects of tangram on cognitive function in patients with Alzheimer's disease
Acronym Effects of tangram in patients with Alzheimer's disease
Scientific Title Effects of tangram on cognitive function in patients with Alzheimer's disease
Scientific Title:Acronym Effects of tangram in patients with Alzheimer's disease
Region
Japan

Condition
Condition Alzheimer's disease
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 Alzheimer's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Score of MMSE
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 According to print play Tangram games.
The treatment time is 30-40 minutes.2-3 times per week, during 3 month.
Do MMSE test very 30 days and record the score.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Outpatient diagnosed by Mild Alzheimer's Disease and get Mini-Mental state examination score between 17 to 30, age from 40 to 65 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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Narimasa Katsuta
Organization Juntendo University
Division name Psychiatry
Zip code
Address 2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL 03-5802-1071
Email nkatsuta@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Narimasa Katsuta
Organization Juntendo University
Division name Psychiatry
Zip code
Address 2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL 03-5802-1071
Homepage URL
Email nkatsuta@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 25 Day
Last follow-up date
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
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039495

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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