Exploratory Study for the Validity of QuQu Scale

Alzheimer Dementia Clinical Trial

— QuQu  

Official title:

Exploratory 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: NCT02267486
• Other study ID #: TRIAD1402
• Secondary ID: UMIN000016394
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: July 14, 2016
• Start date: October 2014

Study information

• Verified date: July 2016
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Central ethics board
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 972
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Alzheimer Dementia (AD) patients 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 Dementia (AD)

3. patients with other severe neurological disease or psychiatric disorder without Alzheimer Dementia (AD)

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Dementia

Intervention

Other:
• Standard therapy of Alzheimer Dementia (AD)

• Observation

Locations

Country	Name	City	State
Japan	Kagawa University School of Medicine	Kida-gun	Kagawa

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	Novel Dementia Rating Scale (QUick QUestion Scale)		1 day	No