UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the assessment tools for early detection of mild cognitive impairment
Title of the study (Brief title)	Making the checklists for MCI
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To development of new assessment tool for early detection of Mild Cognitive Impairment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Convenience for medical doctors, chemists and nurses. Satisfaction for patients and patients' family.
Key secondary outcomes

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

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who can understand the explanation of the study and agree it.
Key exclusion criteria	Patients who cannot understand the explanation of the study or who do not agree it.
Target sample size	1000

Research contact person
Name of lead principal investigator	Takashi Asada
Organization	Tokyo Medical and Dental University
Division name	Psychiatry
Address	1-5-45, Yushima, Bunkoy-ku, Tokyo
TEL	03-6801-8718
Email	asada@memory-cl.jp

Public contact
Name of contact person	Yasuko Abe
Organization	Tokyo Medical and Dental University
Division name	Geriatrics and Vascular Medicine
Address	1-5-45, Yushima, Bunkoy-ku, Tokyo
TEL	03-5803-5229
Homepage URL
Email	yk.abe.vasc@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japanese Psychogeriatric Society
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	From now on, we will start this study at the medical office or consultation room.

Management information
Registered date	2016 Year 08 Month 01 Day
Last modified on	2016 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023595