UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study to evaluate the reactivity of changing the prescription for Alzheimer's Disease Dementia by using the ABC Dementia Scale.
Title of the study (Brief title)	An exploratory study to evaluate the reactivity of changing the prescription.
Region	Japan

Condition
Condition	Alzheimer's Disease
Classification by specialty	Neurology Geriatrics Psychiatry Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study enrolls Alzheimer's disease patients taking medication. By using ABC dementia scale, we assess whether the effect of the alteration of medication improves the patient's conditions. The purpose of the alternation should not be alleviation of adverse events or improvement of poor medication compliance.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Difference of three-dimensional distance of the ABC dementia scale between baseline and 12th week
Key secondary outcomes	Domain scores and total scores of the ABC dementia scale FAST HDS-R Three items of the ABC dementia scale selected by the doctor in charge who expects the improvement of the conditions described in the items.

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 before 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 be inappropriate for the subject of this study (e.g., inappropriate for the evaluation of dementia rating scale)
Target sample size	100

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

Sponsor
Institute	Department of Neuropsychiatry, 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	TRIAD1710
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

うえき老年メンタル・認知症クリニック（兵庫県）、上田脳神経外科（宮崎県）、桶狭間病院藤田こころケアセンター（愛知県）、香川大学医学部附属病院（香川県）、くどうちあき脳神経外科クリニック（東京都）、くるみクリニック（東京都）、慈圭病院（岡山県）、湘南いなほクリニック（神奈川県）、東京大学医学部附属病院（東京都）、菜の花診療所（高知県）、原田医院（山口県）、牧病院（愛媛県）、三豊市立西香川病院（香川県） Ueki Dementia and Geriatric Psychiatry Clinic、Medical Corporation Koujinkai,Uedaneurosurgical Clinic、Okehazama Hospital Fujita Kokoro Care Center、Kagawa University Hospital、KUDOH CHIAKI Clinic for Neurosurgery & Neurology、Kurumi Clinic、Zikei hospital、Shonan Inaho Clinic、The University of Tokyo Hospital、Nanohana Clinic、HARADA CLINIC、MAKI HOSPITAL、Mitoyo City Nishikagawa Hospital

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 17 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2018 Year 05 Month 09 Day
Date of closure to data entry	2018 Year 06 Month 30 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	This study is a prospective observational study. The participants are all those who met the inclusion criteria for patients who visit the trial institutions from 1 November 2017 to 31 January 2018.

Management information
Registered date	2017 Year 10 Month 18 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=R000033826