UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029610 |
|---|---|
| Receipt number | R000033826 |
| Scientific Title | An exploratory study to evaluate the reactivity of changing the prescription for Alzheimer's Disease Dementia by using the ABC Dementia Scale. |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2018/10/18 12:39:25 |
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Basic information
Public title
An exploratory study to evaluate the reactivity of changing the prescription for Alzheimer's Disease Dementia by using the ABC Dementia Scale.
Acronym
An exploratory study to evaluate the reactivity of changing the prescription.
Scientific Title
An exploratory study to evaluate the reactivity of changing the prescription for Alzheimer's Disease Dementia by using the ABC Dementia Scale.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yu Nakamura |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
1750-1, Ikenobe, 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
1750-1, Ikenobe, 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
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
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 |
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
| 2017 | Year | 10 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033826
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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