UMIN-CTR Clinical Trial

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	https://bmjopen.bmj.com/content/11/7/e043768
Publication of results	Partially published

Result
URL related to results and publications	https://bmjopen.bmj.com/content/11/7/e043768
Number of participants that the trial has enrolled	44303
Results	In addition to older age and female sex, use of the following medications was significantly associated with NPADM: statins (HR: 0.82; p=0.001), antihypertensives (HR: 0.80; p<0.0001), non-steroidal bronchodilators (HR: 0.728; p=0.002), antidepressants (HR: 1.79; p<0.0001), poststroke medications (HR: 1.45; p=0.002), insulin (HR: 1.34; p=0.046) and antineoplastics (HR: 1.12; p=0.035).
Results date posted	2021 Year 07 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	A total of 42024 adults aged more than 76 years residing in Kashiwa City, a suburban city of Tokyo Metropolitan Area, who did not have any prscription of antidementia medication from 1 April to 30 June 2012.
Participant flow	follow-up period until 31 March 2015 (35 months)
Adverse events	None
Outcome measures	the initiation of a new prescription of antidementia medication (NPADM).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
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	2021 Year 07 Month 27 Day

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