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Amyloid Accumulation After Mild Traumatic Brain Injury (TBI)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02134041
Recruitment Status : Recruiting
First Posted : May 8, 2014
Last Update Posted : September 19, 2019
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Observational Study for Amyloid Accumulation After Mild Traumatic Brain
Study Start Date : October 2012
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : September 18, 2019

Group/Cohort Intervention/treatment
traumatic brain injury
mild traumatic brain injury
Other: traumatic brain injury
mild TBI, GCS >/=13 after traumatic brain injury
Other Name: TBI

without TBI
without TBI

Primary Outcome Measures :
  1. amyloid accumulation by amyloid PET [ Time Frame: day one ]
    amyloid PET after participation

Secondary Outcome Measures :
  1. 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

Other Outcome Measures:
  1. APOE genotypes [ Time Frame: day one ]

Biospecimen Retention:   Samples With DNA
peripheral blood for APOE genotyping

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients aged over 55 years with/without traumatic brain injury 1, 5, 10, 15 years ago

Inclusion Criteria:

  • a. had TBI in 1, 5, 10 and 15 years ago b. mild injury in TBI (initial GCS = 13-15) c. had MRI or CT evaluation after TBI d. aged 18 years or older (55 years better) e. have agreement and have signed the informed consent form by him/herself or his/her legal representative

Exclusion Criteria:

  • a. participating in another clinical trials which might interfere the current finding b. not sure the timing of TBI c. contaminant the symptoms with injury, skull fracture, intracranial hemorrhage, craniotomy, and death d. moderate (initial GCS = 9-12) or severe (initial GCS < 8) injury in TBI e. had wound with gunshot or puncture f. loss of consciousness over 30 minutes after TBI g. loss of memory for over 1 day after TBI h. have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI or CT evaluation i. have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and other major diseases j. pregnant woman or emotional instability k. the age less than 18 years (55 years better) l. unable to collect blood sample by peripheral vein m. determination of inappropriate participants in the clinical trail of PI

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 identifier (NCT number): NCT02134041

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Contact: Chaur-Jong Hu, M.D. 886-2-22490088 ext 8112

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Shuang Ho Hospital, Taipei Medical University Recruiting
New Taipei City, Taiwan, 235
Contact: Chaur-Jong Hu, M.D.    886-22490088 ext 8112   
Principal Investigator: Chaur-Jong Hu, M.D.         
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Chang Gung Memorial Hospital
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Principal Investigator: Chaur-Jong Hu, M.D. Department of Neurology, Shuang Ho Hospital, Taipei medical University
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Responsible Party: Chaur-jong Hu, Chief, Department of Neurology, Taipei Medical University Shuang Ho Hospital Identifier: NCT02134041    
Other Study ID Numbers: DOH101-TD-PB-111-NSC017
DOH101-TD-PB-111-NSC017 ( Other Grant/Funding Number: National Scince council of Taiwan )
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital:
traumatic brain injury
Alzheimer disease
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System