DementiafMRINCT01287819
Apolipoprotein E Gene and Functional MRI
An observational study of Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2012to 18 Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: people aged 45-65 years taking health examination in TMU SHH no cognitive impairment by MMSE and AD8 screening
Who may be able to join
- people aged 45-65 years without cognitive impairment
Who cannot join
- unable to take APOE genotyping or undergo functional MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| APOE4 (+) and APE4 (-) | APOE4 (+) 10 people APOE4 (-) 20 people from 200 participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: every 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startMay 2012
- Primary completion17 Apr 2013
- Study completion18 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital
- Investigators
- Chaur-Jong Hu, M.D., Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287819
- Sponsor's protocol ID
- CRC-12-10-04
- Acronym
- fMRI
- Status last verified
- Sep 2019
- First submitted
- 31 Jan 2011
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen CJ, Chen CC, Wu D, Chi NF, Chen PC, Liao YP, Chiu HW, Hu CJ. Effects of the apolipoprotein E epsilon4 allele on functional MRI during n-back working memory tasks in healthy middle-aged adults. AJNR Am J Neuroradiol. 2013 Jun-Jul;34(6):1197-202. doi: 10.3174/ajnr.A3369. Epub 2012 Dec 28.
PubMed 23275593
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphisms of Apolipoprotein E Gene and the Presentation of Resting-state Functional MRI
- ClinicalTrials.gov ID
- NCT01287819
- Acronym / sponsor ID
- fMRI / CRC-12-10-04
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital
- Study start
- May 2012
- Primary completion
- 17 Apr 2013 (actual)
- Study completion
- 18 Apr 2013 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APOE4 (+) and APE4 (-) | – | –APOE4 (+) 10 people APOE4 (-) 20 people from 200 participants |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- people aged 45-65 years taking health examination in TMU SHH no cognitive impairment by MMSE and AD8 screening
Key inclusion criteria (1 listed)
- people aged 45-65 years without cognitive impairment
Key exclusion criteria (1 listed)
- unable to take APOE genotyping or undergo functional MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 23275593Chen CJ, Chen CC, Wu D, Chi NF, Chen PC, Liao YP, Chiu HW, Hu CJ. Effects of the apolipoprotein E epsilon4 allele on functional MRI during n-back working memory tasks in healthy middle-aged adults. AJNR Am J Neuroradiol. 2013 Jun-Jul;34(6):1197-202. doi: 10.3174/ajnr.A3369. Epub 2012 Dec 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaur-Jong Hu, M.D. principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amyloid load by amyloid-PET examination (time frame: every 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.