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NCT Number: NCT02667665

Verification Study and Reactivity Study for the Validity of QuQu Scale

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.

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Key information

Conditions

Alzheimer's Disease Dementia Cognitive Concern Without Dementia

Sex eligibility

All sexes

Study type

Observational

Primary location

Kagawa University School of Medicine

Kitagun, Kagawa-ken, 761-0793, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Daiichi Sankyo Co., Ltd.

Registry information

Official study title

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

Acronym: QuQu

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 29, 2016
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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