Exploratory Study for the Validity of QuQu Scale | NCT02267486

Studies
Exploratory Study for the Validity of QuQu Scale

NCT02267486

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status

Completed

Last Update Posted

Jul 15, 2016Estimated

Enrollment

972Actual

Phase

Not provided

Conditions

Alzheimer Dementia

Interventions

Standard therapy of Alzheimer Dementia (AD)
Observation

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN000016394	Other Identifier	UMIN-CTR

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Not provided

First Submitted Date

Oct 14, 2014

First Submission Date that Met QC Criteria

Oct 16, 2014

First Posted Date

Oct 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2016

Last Update Posted Date

Jul 15, 2016Estimated

Name	Class
Daiichi Sankyo Co., Ltd.	INDUSTRY

Description Module

Brief Summary

Examine the construct validity, the group discriminant ability, and the inter-rater reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate for the evaluation of patients with Alzheimer Dementia (AD)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

972Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alzheimer Dementia (AD)		Patients with dementia caused by Alzheimer's disease	Other: Standard therapy of Alzheimer Dementia (AD)
Non-dementia		Patients with cognitive concern without dementia	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard therapy of Alzheimer Dementia (AD)	Other		Alzheimer Dementia (AD)
Observation

Measure	Description	Time Frame
Novel Dementia Rating Scale (QUick QUestion Scale)		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alzheimer Dementia (AD) patients and patients with cognitive concern without dementia
Written Informed consent by each subject and/or a legal representative, and study informant. If the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. If not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease.

Exclusion Criteria:

patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia)
patients with other diseases which cause secondary dementia prior to Alzheimer Dementia (AD)
patients with other severe neurological disease or psychiatric disorder without Alzheimer Dementia (AD)
patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Alzheimer Dementia (AD), non-dementia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu Nakamura	Kagawa University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kagawa University School of Medicine		Kida-gun	Kagawa-ken	761-0793	Japan

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D008722	Methods
D008919	Investigative Techniques