- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134041
Amyloid Accumulation After Mild Traumatic Brain Injury (TBI)
Observational Study for Amyloid Accumulation After Mild Traumatic Brain
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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New Taipei City, Taiwan, 235
- Recruiting
- Shuang Ho Hospital, Taipei Medical University
-
Contact:
- Chaur-Jong Hu, M.D.
- Phone Number: 8112 886-22490088
- Email: chaurjongh@tmu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
traumatic brain injury
mild traumatic brain injury
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mild TBI, GCS >/=13 after traumatic brain injury
Other Names:
|
without TBI
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amyloid accumulation by amyloid PET
Time Frame: day one
|
amyloid PET after participation
|
day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day one
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
APOE genotypes
Time Frame: day one
|
day one
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chaur-Jong Hu, M.D., Department of Neurology, Shuang Ho Hospital, Taipei medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DOH101-TD-PB-111-NSC017 (Other Grant/Funding Number: National Scince council of Taiwan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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