This is a single site, open-label study designed to examine dopamine transporter density using \[123I\]β-CIT SPECT imaging before and following treatment with IRX4204 for a 30-day period in early Parkinson's disease patients. In addition, clinical evaluations will be performed to evaluate the effect of IRX4204 treatment on the motor and cognitive symptoms of PD.
Fifteen patients with early PD were enrolled in this open label study, in 3 cohorts of 5 patients each, treated with IRX4204 at 5 mg/day, 10mg/day, or 20 mg/day. Patients were administered IRX4204 orally once daily. Baseline assessments were performed for total motor score, and Unified Parkinson's Disease Rating Scale (UPDRS). Follow-up assessments of these clinical outcome measures were performed at 14 and 29 days of treatment. \[123\]β-CIT SPECT imaging for assessment of dopamine active transporter (DAT) expression was performed at baseline, and on day 30 of IRX4204 treatment. Patients had clinical hematology and chemistry laboratory tests, and recording of adverse events, performed at baseline and at follow up visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
IRX4204 is a potent and highly selective orally available and brain penetrant RXR nuclear receptor agonist small compound administered as gel capsules.
Molecular NeuroImaging, [MNI]
New Haven, Connecticut, United States
striatal binding ratio (SBR)
The percent change from baseline to end of dosing period (Day 30) of the striatal binding ratio (SBR)
Time frame: 30 days
Total Motor and UPDRS scores
The change in motor and UPDRS scores to end of dosing period (Day 30)
Time frame: 30 days
Safety including hematology and chemistry laboratories, vital signs, and adverse events
Clinically significant changes in hematology and chemistry laboratories, vital signs, and frequency of adverse events
Time frame: 30 Days
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