- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267486
Exploratory Study for the Validity of QuQu Scale (QuQu)
July 14, 2016 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Exploratory Study for the Validity of a Novel Dementia Rating Scale (QUick QUestion Scale) for Alzheimer's Disease Dementia
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
972
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
-
-
Kagawa
-
Kida-gun, Kagawa, 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
Alzheimer Dementia (AD), non-dementia
Description
Inclusion Criteria:
- Alzheimer Dementia (AD) patients 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 Dementia (AD)
- patients with other severe neurological disease or psychiatric disorder without Alzheimer Dementia (AD)
- 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 |
Intervention / Treatment |
---|---|
Alzheimer Dementia (AD)
Patients with dementia caused by Alzheimer's disease
|
|
Non-dementia
Patients with cognitive concern without dementia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Novel Dementia Rating Scale (QUick QUestion Scale)
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yu Nakamura, 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
October 1, 2014
Primary Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
October 16, 2014
First Posted (Estimate)
October 17, 2014
Study Record Updates
Last Update Posted (Estimate)
July 15, 2016
Last Update Submitted That Met QC Criteria
July 14, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRIAD1402
- UMIN000016394 (Other Identifier: UMIN-CTR)
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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