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
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
Treatments tested in this trial
- [11C]CPPC PET ligand
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov