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Clinical Trial Summary

1. Establish the safety and tolerability of the 5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide ([11C]CPPC) PET radioligand in ALS patients and controls 2. Examine whether [11C]CPPC PET uptake is elevated in brains of ALS patients and whether there is a correlation with clinical phenotype. 3. Correlate [11C]CPPC PET imaging with other ALS outcome measures and biofluid biomarkers 4. Examine longitudinal changes in [11C]CPPC PET imaging during disease course.


Clinical Trial Description

There are a paucity of reliable serum and cerebrospinal (CSF) biomarkers and validated neuroimaging techniques to aid in amyotrophic lateral sclerosis (ALS) diagnosis, prognosis, or pharmacodynamic insight. Positron emission tomography (PET) imaging is a technique that uses radioactive molecules attached to a ligand of interest which localizes to the desired target, allowing for visualization of the three dimensional distribution of the ligand's target receptor. One of the upstream processes that are thought to lead to motor neuron degeneration in ALS is microglial dysfunction, resulting in the initiation of neuroinflammatory cascades. Macrophage colony stimulating factor 1 receptor (CSF1R) is found on microglia predominately in the brain, with low levels of expression in neurons and other neural cells, making it a promising target for studying microglial activation. Given CSF1's potential role in ALS disease progression, and that its receptor (CSF1R) can be directly targeted, ligands binding this receptor are an area of interest for imaging in ALS. [11C]CPPC [5-cyano-N-(4-(4-[11C]methylpiperazin-1-yl)-2-(piperidin-1-yl)phenyl)furan-2-carboxamide], is a positron-emitting, high-affinity ligand that is specific for CSF1R. The aims of this study are as follows: 1. Establish the safety and tolerability of the [11C]CPPC PET radioligand in ALS patients and controls 2. Examine whether [11C]CPPC PET uptake is elevated in brains of ALS patients and whether there is a correlation with clinical phenotype. 3. Correlate [11C]CPPC PET imaging with other ALS outcome measures and biofluid biomarkers 4. Examine longitudinal changes in [11C]CPPC PET imaging during disease course. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05602142
Study type Interventional
Source Johns Hopkins University
Contact JinAe Arneklev, CRNP
Phone 410-502-2932
Email jarnekl1@jhu.edu
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date July 2024
Completion date July 2026

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