Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PET

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis; Healthy Volunteers
• Interventions: Drug: [18F]PBR06

• Registration Number: NCT03876002
• Lead Sponsor: Molecular NeuroImaging

Brief Summary

The overall goal of this protocol is to evaluate microglial activation in the brain using \[18F\]PBR06 in patients with amyotrophic lateral sclerosis (ALS).

Detailed Description

The overall goal of this protocol is to evaluate microglial activation in the brain using \[18F\]PBR06 in patients with amyotrophic lateral sclerosis (ALS). The specific objectives are:

* To measure the dynamic uptake and washout of \[18F\]PBR06 (Peripheral benzodiazepine receptor-06) in brain using positron emission tomography (PET) in patients with ALS and healthy volunteers (HV).

* To evaluate test/retest reliability of the tracer binding parameters in patients with ALS and HV.

* To evaluate the correlation of \[18F\]PBR06 binding with ALS disease clinical severity (ALSFRS-R, upper motor neuron burden (UMNB) and Ashworth Score), clinical disease sub-categorization, and other clinical data.

* To perform kinetic modeling using plasma-based (metabolite corrected plasma concentration) or reference region based methods or simplified quantification methods to assess the ability of \[18F\]PBR06 PET to measure microglial activation in brain.

* To acquire safety data following injection of \[18F\]PBR06.

Study Timeline

• Study Start: 2016-06-28
• Primary Completion: 2018-02-07
• Study Completion: 2018-02-07
• Status Verified: 2019-03
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]PBR06	[18F]PBR06	To perform kinetic modeling using plasma-based (metabolite corrected plasma concentration) or reference region based methods or simplified quantification methods to assess the ability of \[18F\]PBR06 PET to measure microglial activation in brain.

Primary Outcome Measures

Name	Time	Method
Time-activity data	1 year	Time-activity data will be analyzed with 2-tissue compartment model, using the radiometabolite-corrected plasma input function. To correct the brain data for its vascular component, radioactivity in serial whole blood will be measured and then subtracted from the PET measurements. Non-invasive simple tissue ratio methods will also be evaluated.

Trial Locations

Locations (1)

Molecular NeuroImaging, LLC; 🇺🇸 New Haven, Connecticut, United States