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

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: [18F] PBR111

• Registration Number: NCT01209156
• Lead Sponsor: Institute for Neurodegenerative Disorders

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-27
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Assess [18F] PBR111 and PET imaging	[18F] PBR111	Evaluation of PET imaging with \[18F\]PBR111 in HV and AD subjects (Proof of Mechanism)

Primary Outcome Measures

Name	Time	Method
To evaluate the cerebral distribution of [18F]PBR-111 positron emission tomography (PET) for detection/exclusion of microglial activation in patients with Alzheimer Disease compared to healthy volunteers.	1 year

Secondary Outcome Measures

Name	Time	Method
To assess the dynamic uptake and washout of [18F]PBR-111, a potential imaging biomarker for inflammatory changes in brain, using positron emission tomography (PET) in Alzheimer disease subjects compared to healthy volunteers.	1 year
To perform blood metabolite characterization of [18F]PBR-111 in AD subjects compared to Healthy volunteers to determine the nature of metabolites in assessment of [18F]PBR-111 as a single positron computed tomography (PET) brain imaging agent.	1 year

Trial Locations

Locations (1)

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States