Trial record 1 of 734 for:    Traumatic Brain Injury
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Amyloid Accumulation After Mild Traumatic Brain Injury

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01871610
First received: May 2, 2013
Last updated: June 3, 2013
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Drug: [18F]AV-45 PET amyloid binding imaging
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Amyloid Accumulation After Mild Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • The amyloids load in brain among mild traumatic brain injury and controls in a temporal manner. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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:
  • F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    To evaluate the the F-18-AV-45 binding in different APOE genotypes among mild traumatic brain injury and controls


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: October 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871610

Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Tzu-Chen YEN, MD, PhD Nuclear Medicine
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01871610     History of Changes
Other Study ID Numbers: 100-4313A
Study First Received: May 2, 2013
Last Updated: June 3, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:
Traumatic brain injury
mild TBI
Alzheimer's disease
[18F]AV-45 PET amyloid binding imaging

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014