UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049245 |
|---|---|
| Receipt number | R000056079 |
| Scientific Title | Diagnostic study on retinal amyloid deposition and dementia development in glaucoma patients |
| Date of disclosure of the study information | 2022/10/18 |
| Last modified on | 2022/10/20 10:51:20 |
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Basic information
Public title
Diagnostic study on retinal amyloid deposition and dementia development in glaucoma patients
Acronym
Association of retinal amyloid deposition and development of dementia
Scientific Title
Diagnostic study on retinal amyloid deposition and dementia development in glaucoma patients
Scientific Title:Acronym
Diagnostic study on retinal amyloid deposition and dementia development in glaucoma patients
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After oral administration of curcumin to glaucoma patients, retinal amyloid imaging using scanning laser ophthalmoscope is performed to examine whether the deposition of amyloid in the retina is different from that of healthy controls (cataract patients). We will also investigate the relationship between retinal amyloid deposition and cognitive function in glaucoma patients divided into three groups according to their degree of progression.
Basic objectives2
Others
Basic objectives -Others
Retinal amyloid deposits
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences between glaucoma patients, cataract patients and healthy subjects regarding the parameters obtained by retinal amyloid imaging
Key secondary outcomes
Correlation between parameters acquired by retinal amyloid imaging and cognitive function according to glaucoma severity (glaucoma subgroup analysis)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food | Maneuver |
Interventions/Control_1
Oral curcumin. Take 1g of curcumin daily for 2 consecutive days.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Disease name:Open-angle glaucoma patients, cataract patients
2.Stage:early to middle stage
3.Age:50 years old or older, 85 years old or younger(at the time of registration)
4.Gender:Regardless of gender
Key exclusion criteria
1.Those who have severe dysphagia and have difficulty taking curcumin supplements
2.Alcohol addiction, drug addiction patients
3.Those who cannot follow the protocol of this study such as oral administration and fundus examination due to severe cognitive decline.
4.Those who have been administered corticosteroids within 1 month
5.Those with gallbladder disease, gallstones, gastrointestinal disorders
6.Those who have been diagnosed with angle-closure glaucoma and have difficulty in mydriasis
7.Those who cannot perform visual field test or OCT, those who have difficulty in fundus examination and cannot see through the fundus with SLO
8.Those who have severe vision loss (need assistance in daily life due to visual impairment)
9.Those who are judged by the principal investigator or research coordinator to be unsuitable for participation in the research
10.Pregnant women, lactating women, those who wish to become pregnant during the research period
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574,Japan
TEL
022-717-7294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ishikawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574,Japan
TEL
022-717-7294
Homepage URL
ishikawa-m@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-machi, Aoba-ku, Sendai,Miyagi 980-8574,Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
東北大学病院 Tohoku University Hospital
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056079
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
