Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Apolipoprotein E Gene and Functional MRI (fMRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01287819
Recruitment Status : Completed
First Posted : February 1, 2011
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital

Brief Summary:
  1. 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.
  2. Function magnetic resonance imaging (fMRI) is a powerful tool for study of both brain regional functions and brain network.
  3. Study about genetic contribution on fMRI is an emerging concept, which will help on understanding about how the genetics affecting the brain function.

Condition or disease
Dementia

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Polymorphisms of Apolipoprotein E Gene and the Presentation of Resting-state Functional MRI
Study Start Date : May 2012
Actual Primary Completion Date : April 17, 2013
Actual Study Completion Date : April 18, 2013

Resource links provided by the National Library of Medicine


Group/Cohort
APOE4 (+) and APE4 (-)
APOE4 (+) 10 people APOE4 (-) 20 people from 200 participants



Primary Outcome Measures :
  1. amyloid load by amyloid-PET examination [ Time Frame: every 5 years ]
    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.


Biospecimen Retention:   Samples With DNA
DNA


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

  • people aged 45-65 years without cognitive impairment

Exclusion Criteria:

  • unable to take APOE genotyping or undergo functional MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287819


Locations
Layout table for location information
Taiwan
Chaur-Jong Hu
New Taipei City, Taiwan, 235
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chaur-Jong Hu, M.D. Taipei Medical University Shuang Ho Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chaur-jong Hu, Chief of Neurology department, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT01287819     History of Changes
Other Study ID Numbers: CRC-12-10-04
First Posted: February 1, 2011    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders