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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014990
Receipt No. R000017269
Scientific Title Fukui cohort study for early Alzheimer disease
Date of disclosure of the study information 2014/09/10
Last modified on 2020/09/02

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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
Email 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
Email bircfukui@gmail.com

Sponsor
Institute Biomedical Imaging Research Center, University of Fukui
Institute
Department

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
Email 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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 10 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 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
2019 Year 05 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
2014 Year 08 Month 29 Day
Last modified on
2020 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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