This is a proof-of-concept study designed to confirm that human phagocytic cells can be labeled with the near-infrared dye indocyanine green (ICG) and the presence of the labeled cells 48 hours later in cerebral cortex can be inferred using near infrared spectroscopy (NIRS).
To develop a method to detect dendritic cell recruitment in Alzheimer's disease (DC RAD), this study is designed in 2 parts. The first part assesses the safety and efficacy of indocyanine green (ICG) in labeling peripheral immune phagocytic cells in healthy adult subjects. The second part is designed to determine the presence of ICG in the brain of adult subjects diagnosed with Alzheimer's disease (AD). In the first part of the study, ICG will be delivered by intravenous infusion to healthy subjects to verify that peripheral immune phagocytic cells, of which DCs are a subset, can be labeled with ICG. If ICG labeling of phagocytic cells is confirmed, then in the second part of the study the presence of ICG in brain of AD patients, putatively carried in by ICG-labeled cells, will be investigated by NIRS using the INVOS 7000 cerebral oximeter.
Study Type
OBSERVATIONAL
Enrollment
45
CNS, A Division of APEX Innovative Sciences
Long Beach, California, United States
RECRUITINGPharmacodynamic Assessments
Determination of the percent of PBMCs labeled with ICG as measured by appropriate analytical methods. After ICG infusion, determination if there is a NIRS signal in the cortex that is higher than the baseline signal recorded before ICG infusion. The distribution of NIRS signals will be examined across the study population.
Time frame: Day 0 and Day 2
Safety Analysis
Safety analyses will be conducted on all subjects who have started infusion of ICG. The number and percentage of subjects experiencing 1 or more AEs will be summarized by infusion rate, relationship to timing of ICG infusion and severity. AEs and SAE and study withdrawals are characterized. Laboratory, ECG and vital signs are to summarized as changes from baseline values using descriptive statistics.
Time frame: Day 0, Day 2 and 1 Week Telephone Follow-up
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