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Amyloid Accumulation After Mild Traumatic Brain Injury (TBI)

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ClinicalTrials.gov Identifier: NCT02134041
Recruitment Status : Unknown
Verified September 2019 by Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital.
Recruitment status was:  Recruiting
First Posted : May 8, 2014
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital

Tracking Information
First Submitted Date October 15, 2012
First Posted Date May 8, 2014
Last Update Posted Date September 19, 2019
Study Start Date October 2012
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2014)
amyloid accumulation by amyloid PET [ Time Frame: day one ]
amyloid PET after participation
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 6, 2014)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 6, 2014)
APOE genotypes [ Time Frame: day one ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Amyloid Accumulation After Mild Traumatic Brain Injury
Official Title Observational Study for Amyloid Accumulation After Mild Traumatic Brain
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.

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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
peripheral blood for APOE genotyping
Sampling Method Probability Sample
Study Population patients aged over 55 years with/without traumatic brain injury 1, 5, 10, 15 years ago
Condition
  • Traumatic Brain Injury
  • Dementia
  • Alzheimer Disease
Intervention Other: traumatic brain injury
mild TBI, GCS >/=13 after traumatic brain injury
Other Name: TBI
Study Groups/Cohorts
  • traumatic brain injury
    mild traumatic brain injury
    Intervention: Other: traumatic brain injury
  • without TBI
    without TBI
Publications * Lin KJ, Hsu WC, Hsiao IT, Wey SP, Jin LW, Skovronsky D, Wai YY, Chang HP, Lo CW, Yao CH, Yen TC, Kung MP. Whole-body biodistribution and brain PET imaging with [18F]AV-45, a novel amyloid imaging agent--a pilot study. Nucl Med Biol. 2010 May;37(4):497-508. doi: 10.1016/j.nucmedbio.2010.02.003. Epub 2010 Apr 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 6, 2014)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 18, 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02134041
Other Study ID Numbers DOH101-TD-PB-111-NSC017
DOH101-TD-PB-111-NSC017 ( Other Grant/Funding Number: National Scince council of Taiwan )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Chaur-jong Hu, Taipei Medical University Shuang Ho Hospital
Study Sponsor Taipei Medical University Shuang Ho Hospital
Collaborators Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chaur-Jong Hu, M.D. Department of Neurology, Shuang Ho Hospital, Taipei medical University
PRS Account Taipei Medical University Shuang Ho Hospital
Verification Date September 2019