NCT01287819

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2013

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2013

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

January 31, 2011

Last Update Submit

September 17, 2019

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

APOE4 (+) and APE4 (-)

APOE4 (+) 10 people APOE4 (-) 20 people from 200 participants

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

people aged 45-65 years taking health examination in TMU SHH no cognitive impairment by MMSE and AD8 screening

You may qualify if:

  • people aged 45-65 years without cognitive impairment

You may not qualify if:

  • unable to take APOE genotyping or undergo functional MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaur-Jong Hu

New Taipei City, 235, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 23275593DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Chaur-Jong Hu, M.D.

    Taipei Medical University Shuang Ho Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Neurology department

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 1, 2011

Study Start

May 1, 2012

Primary Completion

April 17, 2013

Study Completion

April 18, 2013

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

TW(1)