Alzheimer's Disease DementiaQuQuNCT02667665
Verification Study and Reactivity Study for the Validity of QuQu Scale
An observational study of Alzheimer's Disease Dementia and Cognitive Concern Without Dementia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease Dementia, Cognitive Concern Without Dementia
- How many people
- 240 participants
- Where
- 1 siteJapan
- Study dates
- 19 Feb 2016to 15 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale "QUick QUestion Scale" for Alzheimer's Disease Dementia
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.
- Keywords
- Alzheimer's Disease Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease Dementia | Not described | |
| non-Dementia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuQu scale candidate
Measured: 12 weeks
Mini-Mental State Examination (MMSE)
Measured: 12 weeks
NPI-Caregiver Distress. Scale(NPI-D)
Measured: 12 weeks
Disability Assessment for Dementia (DAD)
Measured: 12 weeks
Clinical Dementia Rating
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start19 Feb 2016
- Primary completion15 Nov 2016
- Study completion15 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yu Nakamura, Professor, Study chair, Kagawa University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667665
- Sponsor's protocol ID
- TRIAD1412
- Acronym
- QuQu
- Status last verified
- Jun 2017
- First submitted
- 26 Jan 2016
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification Study and Reactivity Study for the Validity of a Novel Dementia Rating Scale "QUick QUestion Scale" for Alzheimer's Disease Dementia
- ClinicalTrials.gov ID
- NCT02667665
- Acronym / sponsor ID
- QuQu / TRIAD1412
- Keywords
- Alzheimer's Disease Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- 19 Feb 2016 (actual)
- Primary completion
- 15 Nov 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease Dementia | – | – |
| non-Dementia | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QuQu scale candidate
Time frame: 12 weeks
Mini-Mental State Examination (MMSE)
Time frame: 12 weeks
NPI-Caregiver Distress. Scale(NPI-D)
Time frame: 12 weeks
Disability Assessment for Dementia (DAD)
Time frame: 12 weeks
Clinical Dementia Rating
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Nakamura, Professor study chair
Kagawa University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease Dementia and Cognitive Concern Without Dementia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuQu scale candidate (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017; AzTrials last refreshed its copy on 2 Nov 2026.