Alzheimer DementiaQuQuNCT02267486
Exploratory Study for the Validity of QuQu Scale
An observational study of Alzheimer Dementia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial 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) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- Standard therapy of Alzheimer Dementia (AD) and Observation
- How many people
- 972 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to Mar 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: Alzheimer Dementia (AD), non-dementia
Who may be able to join
- 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.
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 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study for the Validity of a Novel Dementia Rating Scale (QUick QUestion Scale) for Alzheimer's Disease Dementia
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)
- Conditions
- Alzheimer Dementia
- Being tested
- Standard therapy of Alzheimer Dementia (AD), Observation
- Keywords
- Alzheimer Dementia, AD, patients, cognitive
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard therapy of Alzheimer Dementia (AD)Other
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Dementia (AD) | Patients with dementia caused by Alzheimer's disease Receives: Other: Standard therapy of Alzheimer Dementia (AD) | |
| Non-dementia | Patients with cognitive concern without dementia Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel Dementia Rating Scale (QUick QUestion Scale)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Time perspective
- Prospective
- Enrolment
- 972 participants (actual)
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, Principal investigator, Kagawa University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267486
- Sponsor's protocol ID
- TRIAD1402
- Other IDs
- UMIN000016394
- Acronym
- QuQu
- Status last verified
- Jul 2016
- First submitted
- 14 Oct 2014
- Last updated
- 15 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study for the Validity of a Novel Dementia Rating Scale (QUick QUestion Scale) for Alzheimer's Disease Dementia
- ClinicalTrials.gov ID
- NCT02267486
- Acronym / sponsor ID
- QuQu / TRIAD1402
- Conditions
- Alzheimer Dementia
- Keywords
- Alzheimer Dementia, AD, patients, cognitive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 972 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- Oct 2014
- Primary completion
- Mar 2016 (actual)
- First posted
- 17 Oct 2014 (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 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)
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Dementia (AD) | – | Other: Standard therapy of Alzheimer Dementia (AD)Patients with dementia caused by Alzheimer's disease |
| Non-dementia | – | Other: ObservationPatients with cognitive concern without dementia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Alzheimer Dementia (AD), non-dementia
Key inclusion criteria (2 listed)
- 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.
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 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard therapy of Alzheimer Dementia (AD) | Other | Alzheimer Dementia (AD) |
| Observation | Other | Non-dementia |
Primary outcome
Novel Dementia Rating Scale (QUick QUestion Scale)
Time frame: 1 day
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 15 Jul 2016.
Related trials for Alzheimer Dementia
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Active, not recruiting
The PorchLight Project
Memory Loss, Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Alzheimer Disease, Early Onset
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
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 principal investigator
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 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 15 Jul 2016. 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?
Novel Dementia Rating Scale (QUick QUestion Scale) (time frame: 1 day). 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 15 Jul 2016.