NCT04311281

FDDNP Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected CTE and AD

[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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES)
• Suspected Alzheimer's Disease (AD)

Interventions

Type	Name	Description
BIOLOGICAL	[F-18]FDDNP-PET	\[F-18\]FDDNP, or 2-(1-{6-\[(2-\[F-18\]fluoroethyl)(methyl)amino\]-2- naphthyl}ethylidene)malononitrile, is a positron emission tomography (PET) radiotracer developed for the in vivo visualization of tau and amyloid-beta (Aβ) deposition in the brain.

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-05-03
• Completion: 2021-05-03
• First posted: 2020-03-17
• Last updated: 2021-05-06

Regulatory

• FDA-regulated drug study