UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021134 |
|---|---|
| Receipt number | R000024382 |
| Scientific Title | Verification study and reactivity study for the validity of a novel dementia rating scale "QUick QUestion scale" for Alzheimer's Disease Dementia |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2018/10/18 12:25:05 |
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Basic information
Public title
Verification study and reactivity study for the validity of a novel dementia rating scale "QUick QUestion scale" for Alzheimer's Disease Dementia
Acronym
Verification study and reactivity study for the validity of QuQu scale
Scientific Title
Verification study and reactivity study for the validity of a novel dementia rating scale "QUick QUestion scale" for Alzheimer's Disease Dementia
Scientific Title:Acronym
Verification study and reactivity study for the validity of QuQu scale
Region
| Japan |
Condition
Condition
Alzheimer's Disease Dementia patients and patients with cognitive concern without Dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Others
Basic objectives -Others
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
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
QuQu scale final
Key secondary outcomes
MMSE
NPI-D
DAD
CDR contain the sum of Boxes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Alzheimer's Disease Dementia patients and patients with cognitive concern without Dementia
2) 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
1) patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia)
2) patients with other diseases which cause secondary dementia prior to Alzheimer's Disease Dementia
3) patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia
4) 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)
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Nakamura |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
Ikenobe 1750-1, Miki-cho, Kita-gun, Kagawa 761-0793 Japan
TEL
087-891-2167
yunaka@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Nakamura |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
Ikenobe 1750-1, Miki-cho, Kita-gun, Kagawa 761-0793 Japan
TEL
087-891-2167
Homepage URL
yunaka@med.kagawa-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry,Kagawa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
TRIAD1412
Org. issuing International ID_1
Translational Research Informatics Center,Foundation for Biomedical Research and Innovation, Kobe, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
砂川市立病院（北海道）、玉越病院（北海道）、わたべクリニック（山形県）、あずま通りクリニック（福島県）、川瀬神経内科クリニック（新潟県）、旭神経内科リハビリテーション病院（千葉県）、東京大学医学部附属病院（東京都）、康明会病院（東京都）、台東区立台東病院（東京都）、阿部クリニック（東京都）、赤坂山王クリニック（東京都）、ふくろうクリニック等々力（東京都）、湘南いなほクリニック（神奈川県）、八千代病院（愛知県）、本町診療所（大阪府）、田辺脳神経外科病院（大阪府）、やました医院（奈良県）、うえき老年メンタル・認知症クリニック（兵庫県）、ふたば病院（広島県）、原田医院（山口県）、西香川病院（香川県）、香川大学医学部附属病院（香川県）、菜の花診療所（高知県）、牧病院（愛媛県）、田北メモリーメンタルクリニック（福岡県）、山鹿中央病院（熊本県）、上田脳神経外科（宮崎県）、高田中央病院（大分県）、藤田保健衛生大学医学部附属病院（愛知県）、たつのおとしごクリニック（福岡県）、長崎北病院（長崎県）、さなだクリニック（高知県）、くどうちあきクリニック（東京都）、三善病院（福岡県）、賀来メンタルクリニック（福岡県）、たかはしクリニック（滋賀県）、慈圭病院（福岡県）、南草津けやきクリニック（東京都）、桐葉会木島病院（滋賀県）、桶狭間病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 15 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design:multi-institutional joint observational research
Target of this research:all patient who visit our institution between February-19 2016 and November-15 2016.
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2018 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024382
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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