UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054768 |
|---|---|
| Receipt number | R000062586 |
| Scientific Title | Cognitive dysfunction in chronic obstructive pulmonary disease and quantitative analysis of regional brain volumes by MRI imaging. |
| Date of disclosure of the study information | 2024/06/25 |
| Last modified on | 2024/06/25 18:12:50 |
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Basic information
Public title
Cognitive dysfunction in Chronic obstructive pulmonary disease and brain volume
Acronym
Chronic obstructive pulmonary disease and brain volume
Scientific Title
Cognitive dysfunction in chronic obstructive pulmonary disease and quantitative analysis of regional brain volumes by MRI imaging.
Scientific Title:Acronym
Cognitive dysfunction in chronic obstructive pulmonary disease and brain volumes.
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary dise
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to quantify changes in regional brain volumes, mainly in the hippocampus and amygdala, in COPD patients attending EBARA Hospital using brain MRI imaging data, and to clarify the relationship between cognitive dysfunction and morphological brain changes in COPD patients by comparison with healthy controls.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Structural volume of amygdala and hippocampus
Key secondary outcomes
Mini-Mental State Examination, facial expression test, olfactory test
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
| 50 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who were diagnosed with COPD at EBARA Hospital and who gave their consent to participate in this study. The comparison group consisted of healthy adults registered at the Meguro Silver Human Resource Center whose age and gender matched those of the subject group and whose consent to participate in this study had been obtained.
Key exclusion criteria
1) Patients with acute exacerbation of COPD or significant change in symptoms within the past 2 months
2) Patients whose symptoms or physical condition changed drastically in approximately 4 weeks from the date of consent to participate to the start of the study.
3) Patients with concomitant psychiatric or neurological disorders
4) Patients for whom MRI scans are inappropriate (e.g., those with a cardiac pacemaker, implanted defibrillator, cochlear implant, or deep brain stimulator; those with metal in their body such as a cerebral aneurysm surgical clip, artificial valve, or artificial groin; pregnant, etc.)
5) Patients with obvious cognitive decline.
6) Other persons who are judged to be ineligible by the principal investigator or co-investigators.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Okuda |
Organization
Tokyo Metropolitan Ebara Hospital
Division name
Respiratory Medicine
Zip code
145-0065
Address
Higashi-Yukigaya, Ota-ku, Tokyo 145-0065, Japan
TEL
81-3-5734-8000
faustus@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Masaoka |
Organization
Showa University School of Medicine
Division name
Department of Physiology
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawaku, Tokyo, Japan
TEL
0337848113
Homepage URL
faustus@med.showa-u.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Ebara Hospital
Institute
Department
Personal name
Funding Source
Organization
KAKENHI 15K09192
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Ebara Hospital
Address
4-5-10 Higashi-Yukigaya, Ota-ku, Tokyo 145-0065, Japan
Tel
0357348000
faustus@med.showa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 25 | 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
20
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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2024 | Year | 06 | Month | 25 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062586
