UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062429 |
|---|---|
| Receipt number | R000071448 |
| Scientific Title | Assessment of Cognitive Function in Patients with Eosinophilic Granulomatosis with Polyangiitis: Evaluation Using MoCA-J |
| Date of disclosure of the study information | 2026/08/03 |
| Last modified on | 2026/07/31 18:04:49 |
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Basic information
Public title
Assessment of Cognitive Function in Patients with Eosinophilic Granulomatosis with Polyangiitis: Evaluation Using MoCA-J
Acronym
Assessment of Cognitive Function in Patients with Eosinophilic Granulomatosis with Polyangiitis: Evaluation Using MoCA-J
Scientific Title
Assessment of Cognitive Function in Patients with Eosinophilic Granulomatosis with Polyangiitis: Evaluation Using MoCA-J
Scientific Title:Acronym
Assessment of Cognitive Function in Patients with Eosinophilic Granulomatosis with Polyangiitis: Evaluation Using MoCA-J
Region
| Japan |
Condition
Condition
Assessment of Cognitive Function in Patients with Eosinophilic Granulomatosis with Polyangiitis: Evaluation Using MoCA-J
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the frequency of mild cognitive impairment in patients with eosinophilic granulomatosis with polyangiitis.
Basic objectives2
Others
Basic objectives -Others
To retrospectively analyze neuroimaging using MRI, MRA, and SPECT, and investigate the association between imaging findings, including cerebrovascular lesions, and the development of MCI.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of MCI
Key secondary outcomes
1.Association between neuroimaging findings / the Fazekas scale and MCI
2.Association between treatment details and MCI
3.Association between EGPA disease activity (BVAS) and MCI
4.Comparison with the prevalence of MCI in asthma patients from the previous study, "Oral corticosteroids as a risk factor for frailty in severe asthma"
5.Utility of dementia biomarkers in MCI associated with EGPA
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
EGPA Group
1.Patients diagnosed with EGPA based on the Lanham criteria.
2.Patients aged 50 years or older.
Control Asthma Group
1.Patients who participated in the previous study, "Oral corticosteroids as a risk factor for frailty in severe asthma" (all are asthma patients aged 60 years or older).
2.Patients evaluated using the MoCA-J.
Key exclusion criteria
Patients considered unsuitable for this study by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Kamide |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
TEL
042-742-8311
kamide.yosuke.fe@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Aoshiba |
Organization
Sagamihara National Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
252-0392
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
Homepage URL
aoshiba.naoya.ck@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Sagamihara National Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sagamihara National Hospital ethical committee
Address
18-1 Sakuradai Minami-ku Sagamihara, Kanagawa, Japan.
Tel
042-742-8311
sugawara.rumi.rz@mail.hosp.go.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
| 2026 | Year | 08 | Month | 03 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design:
Observational study
Study Period:
January 27,2026 to December 31,2028
Study Subjects:
[EGPA Group]
Patients aged 50 years or older with EGPA who regularly visit the National Hospital Organization Sagamihara Hospital.
[Control Asthma Group]
Patients who participated in the previous study, "Oral corticosteroids as a risk factor for frailty in severe asthma" (secondary use of data acquired in the previous study).
Management information
Registered date
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071448
