NCT02667665CompletedNot Applicable
Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale "QUick QUestion Scale" for Alzheimer's Disease Dementia
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 site in 1 country240 target enrollmentStarted: February 19, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- NPI-Caregiver Distress. Scale(NPI-D)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Alzheimer's Disease Dementia 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's Disease Dementia
- •patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia
- •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)
Outcomes
Primary Outcomes
NPI-Caregiver Distress. Scale(NPI-D)
Time Frame: 12 weeks
Clinical Dementia Rating
Time Frame: 12 weeks
QuQu scale candidate
Time Frame: 12 weeks
Mini-Mental State Examination (MMSE)
Time Frame: 12 weeks
Disability Assessment for Dementia (DAD)
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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