ALS Clinical Trial - Study of [11C]CPPC as a Clinical PET Radioligand

Status Not yet recruiting

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

Clinical Trial Details

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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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study of [11C]CPPC as a Clinical PET Radioligand Biomarker of Microglial Activation in ALS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms