Verification Study and Reactivity Study for the Validity of QuQu Scale

Alzheimer's Disease Dementia Clinical Trial

— QuQu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667665
• Other study ID #: TRIAD1412
• Status: Completed
• Phase: N/A
• First received: January 26, 2016
• Last updated: June 1, 2017
• Start date: February 19, 2016
• Est. completion date: November 15, 2016

Study information

• Verified date: June 2017
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 15, 2016
• Est. primary completion date: November 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease Dementia
• Cognitive Concern Without Dementia
• Dementia

Locations

Country	Name	City	State
Japan	Kagawa University School of Medicine	Kitagun	Kagawa Prefecture

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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