Amyloid Accumulation After Mild Traumatic Brain Injury

Alzheimer Disease Clinical Trial

— TBI  

Official title:

Observational Study for Amyloid Accumulation After Mild Traumatic Brain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02134041
• Other study ID #: DOH101-TD-PB-111-NSC017
• Secondary ID: DOH101-TD-PB-111
• Status: Recruiting
• Start date: October 2012
• Est. completion date: September 18, 2019

Study information

• Verified date: September 2019
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Chaur-Jong Hu, M.D.
• Phone: 886-2-22490088
• Email: chaurjongh[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 18, 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Injuries
• Brain Injuries, Traumatic
• Dementia
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• traumatic brain injury
mild TBI, GCS >/=13 after traumatic brain injury

Locations

Country	Name	City	State
Taiwan	Shuang Ho Hospital, Taipei Medical University	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	APOE genotypes		day one
Primary	amyloid accumulation by amyloid PET	amyloid PET after participation	day one
Secondary	mini-mental status examination (MMSE) for cognitive function	neuro-psychological test by use of mini-mental status examination (MMSE) to measure the cognitive function of participants	day one