UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014990 |
|---|---|
| Receipt number | R000017269 |
| Scientific Title | Fukui cohort study for early Alzheimer disease |
| Date of disclosure of the study information | 2014/09/10 |
| Last modified on | 2024/03/06 13:27:20 |
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Basic information
Public title
Fukui cohort study for early Alzheimer disease
Acronym
Fukui cohort for EAD
Scientific Title
Fukui cohort study for early Alzheimer disease
Scientific Title:Acronym
Fukui cohort for EAD
Region
| Japan |
Condition
Condition
Healthy subjects and patients with MCI
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent AD era, diagnosis method for EAD should be established.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Follow-up study for the participants using brain images and MMSE/HDS-R
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PiB PET PiB-PET positive
Interventions/Control_2
PiB-PET negative
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pisitive subject by CCI (CCI>16)
Key exclusion criteria
Patients with Alzheimer's disease or other dementia.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Okazawa |
Organization
University of Fukui
Division name
Biomedical Imaging Research Center
Zip code
910-1193
Address
23-3 Matsuoka-SHimoaizuki, Eiheiji-cho
TEL
0776-61-8491
okazawa@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Okazawa |
Organization
University of Fukui
Division name
Biomedical Imaging Research Center
Zip code
910-1193
Address
23-3 Matsuoka-SHimoaizuki, Eiheiji-cho
TEL
0776-61-8491
Homepage URL
bircfukui@gmail.com
Sponsor or person
Institute
Biomedical Imaging Research Center, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Biomedical Imaging Research Center, University of Fukui
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
Tel
0776-61-8491
okazawa@u-fukui.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
福井大学
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2076-3921/11/5/1022
Number of participants that the trial has enrolled
20
Results
Preliminary data and results were published in the journal of the Antioxidants.
Okazawa H, Ikawa M, et al. Cerebral oxidative stress in early Alzheimer's disease evaluated by 64Cu-ATSM PET/MRI: A preliminary study. Antioxidants 2022, 11(5), 2022.
Results date posted
| 2022 | Year | 09 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with MCI - early phase dementia in their 45-89 years of age, and healthy volunteers in the same age.
Participant flow
Participants undergo clinical interview, MMSE, and PET/MRI scans with [C-11]PiB, [F-18]MK6240, [Cu-64]ATSM, etc. They are followed up for 1-2 years, and undergo the same exams again.
Adverse events
No adverse event.
Outcome measures
Participants will be divided into 2 groups of positive/negative amyloid and tau, and compared with various other biomarkers. Changes after follow-up will be also evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017269
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