UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038545 |
|---|---|
| Receipt number | R000043926 |
| Scientific Title | Observational study on patients with mild cognitive impairment by using amyloid PET |
| Date of disclosure of the study information | 2019/11/12 |
| Last modified on | 2021/03/03 15:05:16 |
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Basic information
Public title
Observational study on patients with mild cognitive impairment by using amyloid PET
Acronym
Observational study on patients with mild cognitive impairment by using amyloid PET
Scientific Title
Observational study on patients with mild cognitive impairment by using amyloid PET
Scientific Title:Acronym
Observational study on patients with mild cognitive impairment by using amyloid PET
Region
| Japan |
Condition
Condition
mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between amyloid PET-positive findings and the onset of Alzheimer-type dementia by conducting amyloid PET tests in patients with mild cognitive impairment and observing the subsequent course.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of early dementia based on amyloid PET test
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age at the time of obtaining consent is 20 years old or older, regardless of gender.
2. After verbal and written explanation, consent from the subject has been obtained in writing about participation.
3. Patients with mild cognitive impairment and clinically suspected Alzheimer type dementia as background pathology
Key exclusion criteria
1) Persons who are judged to be inappropriate by the person in charge or in charge of participation in this clinical study
2) Those who have an implantable device such as a pacemaker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka University Graduate School
Division name
Department of Medicine, Department of Psychiatry
Zip code
565-0871
Address
2-2 D3, Yamadaoka, Suita City, Osaka Prefecture
TEL
0668793051
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Hata |
Organization
Osaka University Graduate School
Division name
Department of Medicine, Department of Psychiatry
Zip code
565-0871
Address
2-2 D3, Yamadaoka, Suita City, Osaka Prefecture
TEL
0668793051
Homepage URL
mhata@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita City, Osaka Prefecture
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
| 2019 | Year | 11 | Month | 12 | 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
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2028 | 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
| 2019 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043926
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
