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Verification Study and Reactivity Study for the Validity of QuQu Scale (QuQu)

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ClinicalTrials.gov Identifier: NCT02667665
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
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.

Condition or disease
Alzheimer's Disease Dementia Cognitive Concern Without Dementia

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale "QUick QUestion Scale" for Alzheimer's Disease Dementia
Actual Study Start Date : February 19, 2016
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : November 15, 2016


Group/Cohort
Alzheimer's Disease Dementia
non-Dementia



Primary Outcome Measures :
  1. QuQu scale candidate [ Time Frame: 12 weeks ]
  2. Mini-Mental State Examination (MMSE) [ Time Frame: 12 weeks ]
  3. NPI-Caregiver Distress. Scale(NPI-D) [ Time Frame: 12 weeks ]
  4. Disability Assessment for Dementia (DAD) [ Time Frame: 12 weeks ]
  5. Clinical Dementia Rating [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667665


Locations
Japan
Kagawa University School of Medicine
Kitagun, Kagawa Prefecture, Japan, 761-0793
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Daiichi Sankyo Co., Ltd.
Investigators
Study Chair: Yu Nakamura, Professor Kagawa University School of Medicine

Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT02667665     History of Changes
Other Study ID Numbers: TRIAD1412
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
Alzheimer's Disease Dementia

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders