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

Sponsor
Johns Hopkins University
Study ID
NCT05602142
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [11C]CPPC PET ligand — DRUG
    Radioactive PET ligand to determine microglia expression of colony stimulating factor 1 receptor (CSF1R).

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [11C]CPPC
    All participants will receive \[11C\]CPPC which is a radiotracer ligand that specifically binds to CSF1R.

Primary Outcome Measure

Safety of use of [11C]CPPC in patients with ALS as assessed by adverse events [ Time Frame: Up to 180 days after scan ]

Central Contacts

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