Verification Study and Reactivity Study for the Validity... | NCT02667665

Studies
Verification Study and Reactivity Study for the Validity of QuQu Scale

NCT02667665

Sponsor

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

Status

Completed

Last Update Posted

Jun 2, 2017Actual

Enrollment

240Estimated

Phase

Not provided

Conditions

Alzheimer's Disease Dementia
Cognitive Concern Without Dementia

Interventions

Not provided

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

Status Module

Record Verification Date

Jun 2017

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

Feb 19, 2016Actual

Primary Completion Date

Nov 15, 2016Actual

Completion Date

Nov 15, 2016Actual

First Submitted Date

Jan 26, 2016

First Submission Date that Met QC Criteria

Jan 28, 2016

First Posted Date

Jan 29, 2016Estimated

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

Jun 1, 2017

Last Update Posted Date

Jun 2, 2017Actual

Name	Class
Daiichi Sankyo Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Examine the construct validity, the test-retest reliability, the concurrent validity with the standard dementia rating scales and the reactivity of a novel dementia rating scale "QuQu scale: QUick QUestion scale" final for the evaluation of patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment.

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

240Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QuQu scale candidate		12 weeks
Mini-Mental State Examination (MMSE)		12 weeks
NPI-Caregiver Distress. Scale(NPI-D)		12 weeks
Disability Assessment for Dementia (DAD)		12 weeks
Clinical Dementia Rating		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Alzheimer's Disease Dementia 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's Disease Dementia
patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia
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

Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment

Sampling Method

Non-Probability Sample