Amyloid Accumulation After Mild Traumatic Brain Injury (TBI)
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|ClinicalTrials.gov Identifier: NCT02134041|
Recruitment Status : Unknown
Verified May 2014 by Chaur-Jong Hu, Taipei Medical University Shuang Ho Hospital.
Recruitment status was: Recruiting
First Posted : May 8, 2014
Last Update Posted : May 8, 2014
We are extending the researches of Taiwan neurosurgery traumatic brain injury (TBI) database which is led by Professor WT Chiu in Taipei Medical University and will recruit mild TBI (mTBI) participants who have ever been registered in the database. This database has been established for over 15 years and contains the information of over 150000 patients. It is one of the largest TBI database in the world.
TBI usually results from traffic accidents, falls or violence events. Most of the victims are young people and the victims suffer from life-threatening and mental-physical deficits. Mild TBI (mTBI) usually was neglected before because its symptoms, signs are mild and mTBI patients usually were not obtained enough initial treatment. Therefore, mTBI might result in long-term cognitive and affective impairments, such as depression, indifference, anxiety, memory impairment, loss of attention and executive function. These late effects not only decrease the life quality of patients and their family but also increase the social and medical burden.
Recent epidemiology studies have pointed out that TBI would increase the risk for dementia, especially Alzheimer disease (AD) by 2-4 times. However, the association between TBI severity, number of repeats, genetic factors and onset of AD remains further investigation.
Amyloid-β (Aβ) plaques and neurofibrillary tangles are the pathological hallmarks for AD. Accumulation of Aβ is considered to be the first step of pathophysilogy of AD. Compelling researches have supported TBI accelerates the formation and accumulation of Aβ. These findings could link TBI with AD but the previous researches had limitations. There was lack of mTBI pathology data so the impacts of mTBI on Aβ accumulation were still obscure. By amyloid-PET, we could study the effects of mTBI on the accumulation of Aβ and this tool could be helpful for understanding the real impacts and pathophysiological mechanisms of mTBI on AD.
|Condition or disease||Intervention/treatment|
|Traumatic Brain Injury Dementia Alzheimer Disease||Other: traumatic brain injury|
We will conduct amyloid PET, cognitive examination and APOE genotyping for the individuals who had traumatic brain injury (TBI) in 1 year, 5 years, 10 years and 15 years ago. Age-gender-matched controls without TBI will be recruited.
The main aim of this study is to evaluate the impact of TBI on amyloid accumulation in the brain. In the mean time, we also will test the effects of APOE genotypes in amyloid accumulation after TBI and the clinical relevants, in terms of cognitive function.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Observational Model:||Case Control|
|Official Title:||Observational Study for Amyloid Accumulation After Mild Traumatic Brain|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||December 2014|
traumatic brain injury
mild traumatic brain injury
Other: traumatic brain injury
mild TBI, GCS >/=13 after traumatic brain injury
Other Name: TBI
- amyloid accumulation by amyloid PET [ Time Frame: day one ]amyloid PET after participation
- mini-mental status examination (MMSE) for cognitive function [ Time Frame: day one ]neuro-psychological test by use of mini-mental status examination (MMSE) to measure the cognitive function of participants
- APOE genotypes [ Time Frame: day one ]
Biospecimen Retention: Samples With DNA
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): NCT02134041
|Contact: Chaur-Jong Hu, M.D.||886-2-22490088 ext email@example.com|
|Shuang Ho Hospital, Taipei Medical University||Recruiting|
|New Taipei City, Taiwan, 235|
|Contact: Chaur-Jong Hu, M.D. 886-22490088 ext 8112 firstname.lastname@example.org|
|Principal Investigator: Chaur-Jong Hu, M.D.|
|Principal Investigator:||Chaur-Jong Hu, M.D.||Department of Neurology, Shuang Ho Hospital, Taipei medical University|