UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022642 |
|---|---|
| Receipt number | R000026101 |
| Scientific Title | Early diagnosis of Alzheimer's disease using resting-state fMRI |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2017/01/12 11:35:28 |
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Basic information
Public title
Early diagnosis of Alzheimer's disease using resting-state fMRI
Acronym
Resting-state fMRI in Alzheimer's disease
Scientific Title
Early diagnosis of Alzheimer's disease using resting-state fMRI
Scientific Title:Acronym
Resting-state fMRI in Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer'd disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of re-fMRI in Alzheimer's disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
regional brain function measured by rs-fMRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 75g glucose
Interventions/Control_2
nothing administgration
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
AD patients
1. The subjects who have intention to
participate in this study, and signed
informed consent.
2. Male and female subjects of >=60 and <90 years, old.
Healthy sujbects
1. The subjects who have intention to
participate in this study, and signed
informed consent.
2. Male and female subjects of >=20 and <90 years, old.
Key exclusion criteria
1. The subjects with a history of brain
diseases, excluding than cerebellar
diseases.
2. The subjects who are prescribed a
medication for the central nervous
system.
3. The subject who have chronic
dysfunction in the organs.
4. Pregnant or woman who has a
chance of pregnant.
5. The subjects who were judged by
the clinical investigator to be
inappropriate as a participant in this
study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ishibashi |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
ishibashi@pet.tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Sato |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Neuroimaging
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
sato@pet.tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute of Gerontology
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
Address
Tel
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
| 2016 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 07 | Day |
Last modified on
| 2017 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026101
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
