UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016144 |
|---|---|
| Receipt number | R000018720 |
| Scientific Title | Evaluation of surrogate markers and cognitive reserve related to Alzheimer's disease |
| Date of disclosure of the study information | 2015/01/08 |
| Last modified on | 2018/07/11 11:21:58 |
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Basic information
Public title
Evaluation of surrogate markers and cognitive reserve related to Alzheimer's disease
Acronym
Multimodal Neuroimaging for AD with Biomarker (MULNIAD-B)
Scientific Title
Evaluation of surrogate markers and cognitive reserve related to Alzheimer's disease
Scientific Title:Acronym
Multimodal Neuroimaging for AD with Biomarker (MULNIAD-B)
Region
| Japan |
Condition
Condition
Healthy volunteer
Alzheimer's disease (AD)
Mild cognitive impairment (MCI)
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study that uses PET, MEG and MRI/fMRI are; 1) to visualize the "cognitive reserve" which influences the progression of Alzheimer's disease (AD),and 2) to establish surrogate markers for AD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visualization of cognitive reserve
Detection of surrogate markers for AD
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy young volunteer
2) Cognitively Normal elderly (CN)
3) Intermediate between CN and MCI
4) Mild cognitive impairment (MCI)
5) Alzheimer's disease (AD)
* 1): aged over 20 and less than 50 yrs.
2)-5): aged between 50 and 90 yrs.
Key exclusion criteria
Any significant neurological or psychiatric disease other than dementia
Any significant disease such as cancer and heart disease
Psychiatric symptoms
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Nakamura |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Clinical and Experimental Neuroimaging
Zip code
Address
7-430, Morioka, Obu, Aichi, Japan
TEL
0562-46-2311
nakamura@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Nakamura |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Clinical and Experimental Neuroimaging
Zip code
Address
7-430, Morioka, Obu, Aichi, Japan
TEL
0562-46-2311
Homepage URL
nakamura@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and 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
国立長寿医療研究センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Nakamura A, et al. Early functional network alterations in asymptomatic elders at risk for Alzheimer's disease. Scientific reports. 2017;7(1):6517.
Nakamura A, et al. Electromagnetic signatures of the preclinical and prodromal stages of Alzheimer's disease. Brain. 2018;141(5):1470-1485.
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 | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Cohort Study
This is an extension study of the prior projects UMIN000006419 merged with UMIN000012629. The study takes over all of the datasets from these prior projects.
Management information
Registered date
| 2015 | Year | 01 | Month | 07 | Day |
Last modified on
| 2018 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018720
