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 2023/05/02 16:56:41

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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

Email

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


Email

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

Email

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


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

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

2023 Year 05 Month 02 Day



Link to view the page

Value
https://center6.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