Verification Study and Reactivity Study for the Validity of QuQu Scale (QuQu)

June 1, 2017 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale "QUick QUestion Scale" for Alzheimer's Disease Dementia

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kagawa Prefecture
      • Kitagun, Kagawa Prefecture, Japan, 761-0793
        • Kagawa University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment

Description

Inclusion Criteria:

  1. Alzheimer's Disease Dementia and patients with cognitive concern without Dementia
  2. 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:

  1. patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia)
  2. patients with other diseases which cause secondary dementia prior to Alzheimer's Disease Dementia
  3. patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia
  4. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alzheimer's Disease Dementia
non-Dementia

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Daiichi Sankyo Co., Ltd.

Investigators

  • Study Chair: Yu Nakamura, Professor, Kagawa University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2016

Primary Completion (Actual)

November 15, 2016

Study Completion (Actual)

November 15, 2016

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 2, 2017

Last Update Submitted That Met QC Criteria

June 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIAD1412

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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