Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction

PHASE2CompletedINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

July 15, 2018

Primary Completion Date

December 28, 2022

Study Completion Date

December 28, 2022

Conditions
Postoperative DeliriumPostoperative Cognitive Dysfunction
Interventions
DRUG

CN-105

"Three doses of CN-105 will be used in three successive cohorts of 50 patients each.~0.1 mg/kg (cohort 1), 0.5 mg/kg (cohort 2), 1 mg/kg (cohort 3)~The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses."

DRUG

Placebo

Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.

Trial Locations (1)

27710

Duke University Hospital, Durham

All Listed Sponsors
lead

Miles Berger, MD PhD

OTHER

NCT03802396 - Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction | Biotech Hunter | Biotech Hunter