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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039040
Receipt No. R000044519
Scientific Title Pharmacological Risk Modification for Progression into Symptomatic Dementia: Complete Enumeration Study Utilizing Administrative Claims Record in Kashiwa City
Date of disclosure of the study information 2020/01/01
Last modified on 2020/01/01

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Basic information
Public title Pharmacological Risk Modification for Progression into Symptomatic Dementia: Complete Enumeration Study Utilizing Administrative Claims Record in Kashiwa City
Acronym Pharmacological Risk Modification for Progression into Symptomatic Dementia
Scientific Title Pharmacological Risk Modification for Progression into Symptomatic Dementia: Complete Enumeration Study Utilizing Administrative Claims Record in Kashiwa City
Scientific Title:Acronym Pharmacological Risk Modification for Progression into Symptomatic Dementia
Region
Japan

Condition
Condition Alzheimer diseases Levy body dementia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to assess the pharmaceutical modification of risks for progression of symptomatic dementia by new prescription of anti-dementia medication
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes New prescription of anti-dementia medication
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
77 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All residents in Kashiwa city who are equal to or older than 77 years old at April 2012
Key exclusion criteria 1. All residents in Kashiwa city who are equal to or younger than 76 years old at April 2012
2. All residents who had prescription of anti-dementia medication while between April and June 2012.
Target sample size 42000

Research contact person
Name of lead principal investigator
1st name Nobuhiro
Middle name
Last name Handa
Organization Pharmaceuticals and medical Devices Agency of Japan
Division name Medical Device Unit
Zip code 100-0013
Address 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, Japan
TEL 03-3506-9447
Email handa-nobuhiro@pmda.go.jp

Public contact
Name of contact person
1st name Nobuhiro
Middle name
Last name Handa
Organization Pharmaceuticals and medical Devices Agency of Japan
Division name Medical Device Unit
Zip code 100-0013
Address 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, Japan
TEL 03-3506-9447
Homepage URL
Email handa-nobuhiro@pmda.go.jp

Sponsor
Institute Tokyo Metropolitan geriatric Medical Center and Institute of Gerontology
Institute
Department

Funding Source
Organization Tokyo Metropolitan geriatric Medical Center and Institute of Gerontology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Pharmaceuticals and medical Devices Agency of Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Metropolitan geriatric Medical Center and Institute of Gerontology
Address 35-2 Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan
Tel 03-3964-3241
Email kouhou@tmghig.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京都健康長寿医療センター研究所

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 44303
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 No longer recruiting
Date of protocol fixation
2019 Year 06 Month 01 Day
Date of IRB
2019 Year 08 Month 01 Day
Anticipated trial start date
2019 Year 08 Month 31 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
2019 Year 10 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 01 Day
Date analysis concluded
2020 Year 01 Month 31 Day

Other
Other related information New prescription of anti-dementia medication is primary endpoint utilizing administrative claims data in residents of Kashiwa city who are equal to or older than 77 year old. The effect of other drugs prescribed simultaneously were evaluated.

Management information
Registered date
2020 Year 01 Month 01 Day
Last modified on
2020 Year 01 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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