UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between language, memory and communicative abilites in normal eldely
Title of the study (Brief title)	Language, memory and communication in normal elderly
Region	Japan

Condition
Condition	normal elderly
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to evaluate the relationship between language, memory and communicative abilites in normal eldely.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary outcomes are to evaluate language, memory and communicative abilites and to know the relationship between them
Key secondary outcomes	Secondary outcomes are to compare the primary outcomes in normals to the date in demented population.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Key inclusion criteia is to be able to sit and respond to the questions.
Key exclusion criteria	Key exclusion criteria is the past history of Cerebro-vascular disorders.
Target sample size	25

Research contact person
Name of lead principal investigator	Takako Yoshimura
Organization	Kyoto Gakuen University
Division name	Speech, language, hearing sciences and disorders
Address	18, Gotanda-cho, Yamanouchi, Ukyo-ku, Kyoto-shi
TEL	075-406-9159
Email	takakoy@kyotogakuen.ac.jp

Public contact
Name of contact person	Taketoshi Hori
Organization	Kyoto Gakuen University
Division name	Research & Community Support Center
Address	1-1, Nanjo-Otani, Sogabe-cho, Kameoka-shi, Kyoto
TEL	0771-22-2001
Homepage URL
Email	hori@kyotogakuen.ac.jp

Sponsor
Institute	Kyoto Gakuen University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	京都学園大学（京都府）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 11 Month 06 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	All subjects could execute all tasks.

Management information
Registered date	2016 Year 04 Month 07 Day
Last modified on	2016 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025152