Amyloid Accumulation After Mild Traumatic Brain Injury

• Conditions: Dementia; Alzheimer Disease; Traumatic Brain Injury
• Interventions: Other: traumatic brain injury

• Registration Number: NCT02134041
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Primary Completion: 2019-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Study Completion: 2019-09-18
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
traumatic brain injury	traumatic brain injury	mild traumatic brain injury

Primary Outcome Measures

Name	Time	Method
amyloid accumulation by amyloid PET	day one	amyloid PET after participation

Secondary Outcome Measures

Name	Time	Method
mini-mental status examination (MMSE) for cognitive function	day one	neuro-psychological test by use of mini-mental status examination (MMSE) to measure the cognitive function of participants

Trial Locations

Locations (1)

Shuang Ho Hospital, Taipei Medical University; 🇨🇳 New Taipei City, Taiwan