Evaluation of [18F] PBR111 and PET as a Marker of Inflammation in Subjects With Neurological Conditions (PBR111)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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|
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Assess [18F] PBR111 and PET imaging
Evaluation of PET imaging with [18F]PBR111 in HV and AD subjects (Proof of Mechanism)
Drug: [18F] PBR111
Subjects will be injected with 5mCi (not to exceed a maximum of 5.5 mCi) of [18F]PBR111, followed by PET imaging.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209156
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna Jennings, MD||Institute for Neurodegenerative Disorders|