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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01287819
Other study ID # CRC-12-10-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date April 18, 2013

Study information

Verified date September 2019
Source Taipei Medical University Shuang Ho Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date April 18, 2013
Est. primary completion date April 17, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

- people aged 45-65 years without cognitive impairment

Exclusion Criteria:

- unable to take APOE genotyping or undergo functional MRI

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Chaur-Jong Hu New Taipei City

Sponsors (2)

Lead Sponsor Collaborator
Taipei Medical University Shuang Ho Hospital Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary amyloid load by amyloid-PET examination 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. every 5 years
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