- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287819
Apolipoprotein E Gene and Functional MRI (fMRI)
September 17, 2019 updated by: Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital
Polymorphisms of Apolipoprotein E Gene and the Presentation of Resting-state Functional MRI
- Apolipoprotein E gene (ApoE) is the most important genetic factor for Alzheimer disease (AD) and an important genetic factor for outcome of brain injury situations.
- Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain regional functions and brain network.
- Study about genetic contribution on fMRI is an emerging concept, which will help on understanding about how the genetics affecting the brain function.
Study Overview
Status
Completed
Conditions
Detailed Description
There are about 4-10% people aged and over 65 years suffering from dementia in Taiwan.
Dementia caused by diverse diseases, including Alzheimer's disease (AD), fronto-temporal dementia (FTD), dementia with Lewy body (DLB), Parkinson's disease dementia (PDD) and vascular dementia (VaD), is a neurodegenerative disease characterized by memory impairment, cognitive dysfunctions, behavioral disturbances and various kinds of psychiatric manifestations.
AD is the most common cause of dementia in the world.
Although the real pathophysiology of AD is still obscure, the compelling evidence has shown genetic factor should play an important role in the occurrence of AD.
There are three genes, in terms of amyloid precursor protein (APP), presenilin-1 (PS1) and presenilin-2 (PS2), linked in the familial AD.
Mutations on these genes would result in familial AD, which account for only less than 5% of AD.
The only one well-documented genetic risk factor for sporadic AD is apolipoprotein E, ε4 allele (ApoE4).
ApoE gene contains three genetic polymorphisms, ε2, 3, 4 and ApoE4 has been found associated with many brain injury situations, such as poor outcome for traumatic brain injury (TBI), Parkinson disease dementia (PDD).
These findings might support ApoE to be important for brain functions but the real mechanisms remain further clarification.
Functional magnetic resonance imaging (fMRI) is a powerful tool for study of both brain regional functions and brain network.
To our knowledge, only few reports in top journals indicated genetic background is an important contributor for fMRI presentations.
This could be a new filed of neuroscience.
In this study, we will explore whether ApoE genetic polymorphisms affect the presentation of fMRI and realize some functions of ApoE in the brain.
In addition, our data could enhance the new concept about the association between genetics and brain function.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Taipei City, Taiwan, 235
- Chaur-Jong Hu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
people aged 45-65 years taking health examination in TMU SHH no cognitive impairment by MMSE and AD8 screening
Description
Inclusion Criteria:
- people aged 45-65 years without cognitive impairment
Exclusion Criteria:
- unable to take APOE genotyping or undergo functional MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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APOE4 (+) and APE4 (-)
APOE4 (+) 10 people APOE4 (-) 20 people from 200 participants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amyloid load by amyloid-PET examination
Time Frame: every 5 years
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The primary end point of this study is the quantity of amyloid load in brain.
The amyloid load will be calculated based on the results of AV45 PET study.
The comparison between mTBI and controls will be conducted by ANOVA test.
The confounders include vascular risks for AD, such as hypertension, diabetes, and APOE genotypes, education.
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every 5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chaur-Jong Hu, M.D., Taipei Medical University Shuang Ho Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
April 17, 2013
Study Completion (Actual)
April 18, 2013
Study Registration Dates
First Submitted
January 31, 2011
First Submitted That Met QC Criteria
January 31, 2011
First Posted (Estimate)
February 1, 2011
Study Record Updates
Last Update Posted (Actual)
September 19, 2019
Last Update Submitted That Met QC Criteria
September 17, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRC-12-10-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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