Amyloid Accumulation After Mild Traumatic Brain Injury
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
Study Overview
Brief Summary
There will be 200 participants, who aged 30 years or older with TBI in 1,5,10,15 years ago and GCS=13-15 will be recruited. Another group of 200 participants with the same age and gender and without TBI will be recruited as the controls. All of them will undergo AD8 questionnaire for dementia screening and APOE4 genotyping. Further CASI and CDR will be tested for the confirmation of dementia diagnosis for the individuals with AD8 scaore >/=2. 10 TBI with dementia, 20 TBI without dementia and 10 controls will be selected randomly for AV45 amylid PET study.
There will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.
Detailed Description
We will examine the mTBI patients in a long-term follow-up manner by cognitive tests and A-PET. This is a novel study for linking mTBI and AD by solid, reliable methods, in terms of A-PET and cognitive function tests. In addition, we will figure out the importance of APOE genotypes for amyloid accumulation and cognitive impairment. These results should shed light on the further clinical studies and amyloid-cleaning therapy for prevention and treatment for dementia after mTBI.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Alzheimer disease after mild traumatic brain injury
Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio
Intervention: [18F]AV-45 PET amyloid binding imaging (Drug)
mild traumatic brain injury without Alzheimer disease
To recruit patients 1, 5, 10, 15 years after mTBI with or without cognitive impairment and age-gender-matched controls (a total of 3 groups) for amyloid- positron emission tomography (A-PET)
Intervention: [18F]AV-45 PET amyloid binding imaging (Drug)
Normal control
People aged 30 or older without mTBI or AD
Intervention: [18F]AV-45 PET amyloid binding imaging (Drug)
Outcomes
Primary Outcomes
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.
Time Frame: one year
The amyloids load (based on F-18-AV-45 binding) in brain among mild traumatic brain injury and controls in a temporal manner.
Secondary Outcomes
- F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls(one year)