UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039040 |
|---|---|
| Receipt number | 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 | 2021/07/27 11:18:43 |
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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
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
handa-nobuhiro@pmda.go.jp
Sponsor or person
Institute
Tokyo Metropolitan geriatric Medical Center and Institute of Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044519
| Research Plan | |
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| Registered date | File name |
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