Verification Study and Reactivity Study for the Validity of QuQu Scale

Completed

• Conditions: Alzheimer's Disease Dementia; Cognitive Concern Without Dementia

• Registration Number: NCT02667665
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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 available

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Study Start: 2016-02-19
• Primary Completion: 2016-11-15
• Study Completion: 2016-11-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kagawa University School of Medicine; 🇯🇵 Kitagun, Kagawa Prefecture, Japan