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

ConditionALS
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures.

Men and women at least 18 years old.

use a condom during sexual intercourse with female partners who are of reproductive potential AND to have female partners use an additional effective means of contraception (e.g., diaphragm plus spermicide, or oral contraceptives) OR

male patient must agree to abstain from sexual intercourse during the study

Disqualifiers

Weakness due to causes other than ALS.

Receipt of any investigational drug, device or biologic within 10 days of administration of study compound.

Use of anti-inflammatory medications, immunosuppressants, or benzodiazepines within 7 days of administration of study compound.

Coagulopathy

Trial design

Design model

Single group

Treatments tested in this trial

  • [11C]CPPC PET ligand

    Drug

    Radioactive PET ligand to determine microglia expression of colony stimulating factor 1 receptor (CSF1R).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: [11C]CPPCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of use of [11C]CPPC in patients with ALS as assessed by adverse events

Safety of use of \[11C\]CPPC in positron emission tomography (PET) neuroimaging of patients with a diagnosis of ALS. Safety will be assessed by number of adverse events during and up to 180 days after the injection

Time frame
Up to 180 days after scan
2

Safety of use of [11C]CPPC in patients with ALS as assessed by a change in neurological status

Safety of use of \[11C\]CPPC in positron emission tomography (PET) neuroimaging of patients with a diagnosis of ALS. Safety will be assessed by neurological physical exam to determine if there is a change in the findings from baseline.

Time frame
Baseline and 180 days after scan
3

Safety of use of [11C]CPPC in patients with ALS as assessed by a change in complete blood count (CBC) test

Safety of use of \[11C\]CPPC in positron emission tomography (PET) neuroimaging of patients with a diagnosis of ALS. Safety will be assessed by monitoring of the complete blood count (CBC) for a change from baseline that is outside of the normal range.

Time frame
Baseline and 180 days after scan
4

Safety of use of [11C]CPPC in patients with ALS as assessed by a change in complete metabolic panel (CMP) test

Safety of use of \[11C\]CPPC in positron emission tomography (PET) neuroimaging of patients with a diagnosis of ALS. Safety will be assessed by a change in the CMP from baseline that is outside of the normal range.

Time frame
Baseline and 180 days after scan

Secondary outcomes

1

Sensitivity of use of [11C]CPPC as assessed by a radiologist

Sensitivity of use of \[11C\]CPPC in PET neuroimaging to detect ALS will be determined by comparing the PET images from patients with ALS with those from healthy controls.

Time frame
Up to 180 days after scan

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: