Evaluation of [18F] PBR111 and PET as a Marker of Inflammation in Subjects With Neurological Conditions — PBR111  

Alzheimer Disease Clinical Trial

Official title: A Phase 1 Evaluation of the Kinetics, Clearance and Cerebral Distribution of One Novel PBR PET Imaging Agent, 18F-PBR-111 Following Intravenous Administration in Healthy Subjects and Alzheimer Disease Patients

Status Completed

Clinical Trial Summary

The underlying goal of this study is to assess PBR-111 positron emission tomography (PET) imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD) research participants and age- and gender-matched healthy volunteers.

Clinical Trial Description

This is a phase 1, open-label, single-center, non-randomized single dose study to assess the kinetics, clearance and cerebral distribution of PBR-111 positron emission tomography (PET) imaging in detecting microglial activation in the brain in patients with probable Alzheimer disease (AD) compared to healthy volunteers (HVs). All aspects related to image acquisition, processing and visual as well as quantitative evaluation will be developed, optimized and validated (where required).

Each subject will be required to visit the study center during the screening phase and on the PBR-111 PET imaging day (baseline). A telephone follow-up visit will be performed 7 days (+/- 3 days) after PBR-111 PET administration.

At the screening visit, each subject (or caregiver in the case of AD subjects) will be asked to provide written informed consent or assent. During the screening phase (maximum duration

• 60 days) subject medical, neurological and surgical history, clinical assessments and a neuro-psychiatric evaluation will be performed on all eligible subjects. Subjects will be allowed to leave the center after all evaluations have been completed. During this period an MRI of the brain will be performed. During the PBR-111 PET imaging day, all subjects will receive a single IV injection of PBR-111 and scanning will be performed over a 3.5 hour period. Each subject will have a telephone follow-up 7 days (+/- 3 days) thereafter to assess for adverse events. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT01209156
• Study type: Interventional
• Source: Institute for Neurodegenerative Disorders
• Status: Completed
• Phase: Phase 1
• Start date: March 2010
• Completion date: June 2013