Amyloid Accumulation After Mild Traumatic Brain Injury

NCT01871610 | Unknown Phase 2 DMC

• 1 other identifier: 100-4313A
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; mild TBI; Alzheimer's disease; [18F]AV-45 PET amyloid binding imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• F-18-AV-45 binding changes and cognitive function among mild traumatic brain injury and controls

  one year

Study Arms (3)

Alzheimer disease after mild traumatic brain injury

EXPERIMENTAL

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

mild traumatic brain injury without Alzheimer disease

EXPERIMENTAL

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

Normal control

EXPERIMENTAL

People aged 30 or older without mTBI or AD

Drug: [18F]AV-45 PET amyloid binding imaging

Interventions

[18F]AV-45 PET amyloid binding imaging DRUG

Alzheimer disease after mild traumatic brain injury; Normal control; mild traumatic brain injury without Alzheimer disease

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tzu-Chen YEN, MD, PhD

  Nuclear Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: June 7, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: October 1, 2013
• Last Updated: June 7, 2013

Record last verified: 2012-06