Amyloid Accumulation After Mild Traumatic Brain Injury

Phase 2

• Conditions: Traumatic Brain Injury
• Interventions: Drug: [18F]AV-45 PET amyloid binding imaging

• Registration Number: NCT01871610
• Lead Sponsor: Chang Gung Memorial Hospital

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 Timeline

• Status Verified: 2012-06
• Study Start: 2012-11
• Primary Completion: 2012-11
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-06-03
• Last Update Submitted: 2013-06-03
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mild traumatic brain injury without Alzheimer disease	[18F]AV-45 PET amyloid binding imaging	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)
Alzheimer disease after mild traumatic brain injury	[18F]AV-45 PET amyloid binding imaging	Based on the TBI registry databank, to recruit patients 1, 5, 10, 15 years after mTBI for cognitive evaluatio
Normal control	[18F]AV-45 PET amyloid binding imaging	People aged 30 or older without mTBI or AD

Primary Outcome Measures

Name	Time	Method
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.	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 Outcome Measures

Name	Time	Method
F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls	one year	To evaluate the the F-18-AV-45 binding in different APOE genotypes among mild traumatic brain injury and controls