BENITIONSClinical Trial Intelligence

Exploratory Open Label Study for Development of a Method To Detect Dendritic Cells

N/A Completed NCT05482867

ConditionProbable Alzheimer's Disease
PhaseN/A
SponsorMindImmune Therapeutics, Inc.
StatusCompleted
Enrollment46 participants
Start dateNov 28, 2022
Completion dateAug 7, 2024
Results postedJul 8, 2026

Summary

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).

Treatment Emergent Adverse Events (TEAEs)

Dosing (Day 0) through Telephone Follow-up (Day 16) · participants

Cohort 13 participants
Cohort 26 participants
Cohort 2A1 participants
Cohort 3A,3 participants
Cohort 37 participants
Cohort4,2 participants

Electrocardiogram Results

Screening, Day 0 and Day 2 · participants

Cohort 12 participants
Cohort 22 participants
Cohort 2A0 participants
Cohort 3A,1 participants
Cohort 34 participants
Cohort 4,1 participants

Mean ICG Concentrations

Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours · ng/mLs

Cohort 12743.76 ng/mLs
Cohort 23388.33 ng/mLs
Cohort 34377.45 ng/mLs
Cohort 2A2591.10 ng/mLs
Cohort 3A,5032.67 ng/mLs
Cohort4,3181.98 ng/mLs

Open in BENITIONS View on ClinicalTrials.gov

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