NCT02667665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

February 19, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2016

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

January 26, 2016

Last Update Submit

June 1, 2017

Conditions

Alzheimer's Disease DementiaCognitive Concern Without Dementia

Keywords

Alzheimer's Disease Dementia

Outcome Measures

Primary Outcomes (5)

  • QuQu scale candidate

    12 weeks

  • Mini-Mental State Examination (MMSE)

    12 weeks

  • NPI-Caregiver Distress. Scale(NPI-D)

    12 weeks

  • Disability Assessment for Dementia (DAD)

    12 weeks

  • Clinical Dementia Rating

    12 weeks

Study Arms (2)

Alzheimer's Disease Dementia

non-Dementia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kagawa University School of Medicine

Kitagun, Kagawa-ken, 761-0793, Japan

Location

Study Officials

  • Yu Nakamura, Professor

    Kagawa University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2016

First Posted

January 29, 2016

Study Start

February 19, 2016

Primary Completion

November 15, 2016

Study Completion

November 15, 2016

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations

JP(1)