Amyloid Accumulation After Mild Traumatic Brain Injury

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.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: [18F]AV-45 PET amyloid binding imaging

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• The individuals are listed in the Taipei medical university traumatic brain injury databank and had TBI in 1, 5, 10 and 15 years ago. There are about 200 individuals undergo telephone interview/invitation, blood test for genotyping and neuropsychological tests. 30 participants will be selected randomly among the 200 individuals.
• mild injury in TBI (initial GCS = 13-15)
• had MRI or CT evaluation after TBI
• aged 30 years or older better
• agreed by principal investigator
• have agreement and have signed the informed consent form by him/herself or his/her legal representative

Main exclusion criteria:

• participating in another clinical trials which might interfere the current finding.
• not sure the timing of TBI
• contaminant the symptoms with injury, skull fracture, intracranial hemorrhage, craniotomy, and death
• moderate (initial GCS = 9-12) or severe (initial GCS < 8) injury in TBI
• had wound with gunshot or puncture
• loss of consciousness over 30 minutes after TBI
• loss of memory for over 1 day after TBI
• have no MRI or CT evaluation of brain after TBI or have obstructive ischemia after MRI or CT evaluation
• have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and other major diseases
• pregnant woman or emotional instability
• the age less than 18 years (30 years better)
• unable to collect blood sample by peripheral vein
• determination of inappropriate participants in the clinical trail of PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: [18F]AV-45 PET amyloid binding imaging
Experimental: 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)	Drug: [18F]AV-45 PET amyloid binding imaging
Experimental: Normal control; People aged 30 or older without mTBI or AD	Drug: [18F]AV-45 PET amyloid binding imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner.	The amyloids load (based on F-18-AV-45 binding) in brain among mild traumatic brain injury and controls in a temporal manner.	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Tzu-Chen YEN, MD, PhD, Nuclear Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: May 2, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Traumatic brain injury; mild TBI; [18F]AV-45 PET amyloid binding imaging
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 100-4313A