[F-18] FDDNP-PET Clinical Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected Chronic Traumatic Encephalopathy and Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES)
- Sponsor
- University of California, Los Angeles
- Primary Endpoint
- Clinical Dementia Rating Sum of Box Scores (CDR-SB)
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called [F-18]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two years.
Detailed Description
The investigators will enroll approximately 180 participants with mild cognitive impairment (90 with suspected Alzheimer's Disease and 90 with suspected Chronic Traumatic Encephalopathy with a history of head trauma). Participants will come to UCLA for 4 visits and will be called twice. The study duration is 2 years. Participants will first complete an over the phone screening to assess their eligibility. If they pass the phone screen, then they will be invited to complete an in-person screen and will sign the informed consent form. They will then undergo a neurological evaluation, blood draw, and neuropsychological testing. Within a month of the screening visit, participants will complete the imaging visit. Participants will undergo a magnetic resonance imaging (MRI) scan, if eligible, and a PET scan with FDDNP. For participants who are unable to undergo an MRI due to contraindications, they will complete a CT scan. Participants will be monitored for possible adverse events following the procedures and will be called 24 hours later and 2 weeks later to assess for any potential adverse events. At the one and two-year follow-up visits, participants' medical history will be reviewed. At this time, they will also complete a neuropsychiatric evaluation, blood draw and neuropsychological testing. Prediction of clinical and cognitive decline from \[F-18\] FDDNP PET scan readers (blinded to clinical evaluations) and clinicians (blinded to \[F-18\]FDDNP PET scan results) will be compared with actual clinical outcomes determined at one and two-year follow-up visits.
Investigators
Helen Lavretsky, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical Dementia Rating Sum of Box Scores (CDR-SB)
Time Frame: 2 years
We propose to use the CDR Sum of Box Scores (CDR-SB) as the primary efficacy endpoint to be predicted (at two-year follow-up) following baseline when the \[F-18\]FDDNP-PET imaging is performed. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. We will use change in CDR-SB score as the common outcome variable. We will convert individual CDR-SB scores into standardized scores by subtracting the baseline mean and dividing by the baseline standard deviation of the study sample (Monsell et al, 2012). Individuals experiencing worsening of cognition by at least 0.5 standard deviation per year in the standardized CDR-SB score will be classified as cognitive decliners; others will be classified as cognitive maintainers.
Secondary Outcomes
- Change in Executive Functioning Domain Score(2 years)
- Conversion to Dementia(2 years)