NCT02267486

Brief Summary

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)

Trial Health

80
On Track

Trial Health Score

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

Enrollment
972

participants targeted

Target at P75+ 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

October 14, 2014

Last Update Submit

July 14, 2016

Conditions

Alzheimer Dementia

Keywords

Alzheimer Dementia, ADpatientscognitive

Outcome Measures

Primary Outcomes (1)

  • Novel Dementia Rating Scale (QUick QUestion Scale)

    1 day

Study Arms (2)

Alzheimer Dementia (AD)

Patients with dementia caused by Alzheimer's disease

Other: Standard therapy of Alzheimer Dementia (AD)

Non-dementia

Patients with cognitive concern without dementia

Other: Observation

Interventions

Standard therapy of Alzheimer Dementia (AD)OTHER
Alzheimer Dementia (AD)
ObservationOTHER
Non-dementia

Eligibility Criteria

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

Alzheimer Dementia (AD), non-dementia

You may qualify if:

  • 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.

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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kagawa University School of Medicine

Kida-gun, Kagawa-ken, 761-0793, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Yu Nakamura

    Kagawa University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2016

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations

JP(1)