UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study for the validity of a novel dementia rating scale "QUick QUestion scale" for Alzheimer's Disease Dementia
Title of the study (Brief title)	Exploratory vstudy for the validity of QuQu scale
Region	Japan

Condition
Condition	Alzheimer's Disease Dementia and patients with cognitive concern without Dementia
Classification by specialty	Neurology Geriatrics Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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's Disease Dementia
Basic objectives2	Others
Basic objectives -Others	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's Disease Dementia
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	QuQu scale candidate
Key secondary outcomes

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 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, front-otemporal dementia) 2) patients with other disease 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	400

Research contact person
Name of lead principal investigator	Yu Nakamura
Organization	Kagawa University School of Medicine
Division name	Department of Psychiatry
Address	Ikedo 1750-1, Miki-cho, Kita-gun, Kagawa 761-0793 Japan
TEL	087-891-2167
Email	yunaka@med.kagawa-u.ac.jp

Public contact
Name of contact person	Yu Nakamura
Organization	Kagawa University School of Medicine
Division name	Department of Psychiatry
Address	Ikedo 1750-1, Miki-cho, Kita-gun, Kagawa 761-0793 Japan
TEL	087-891-2167
Homepage URL
Email	yunaka@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University School of Medicine
Institute
Department

Funding Source
Organization	Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	TRIAD1402
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	2015 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 10 Day
Anticipated trial start date	2015 Year 08 Month 28 Day
Last follow-up date	2015 Year 08 Month 28 Day
Date of closure to data entry
Date trial data considered complete	2015 Year 09 Month 18 Day
Date analysis concluded	2015 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	QuQu scale final is completed.
Other related information	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's Disease Dementia

Management information
Registered date	2015 Year 01 Month 30 Day
Last modified on	2018 Year 10 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019042