Phase 2 N=189 Randomized Quadruple-blind Prevention

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

Postoperative Delirium · Postoperative Cognitive Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT03802396 ↗

Enrolled (actual)

189

Serious AEs

11.8%

Results posted

Sep 2024

Primary outcome: Primary: Number of Adverse Events (AEs) of Grade II or Higher Per Patient — 1; 2 events per participant — p=0.025

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CN-105 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Miles Berger, MD PhD
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events (AEs) of Grade II or Higher Per Patient	1; 2	0.025 sig
SECONDARY Change in Cerebrospinal Fluid (CSF) IL-6 Cytokine Levels Between Drug vs Placebo Treated Patients	0.52; 0.91; -0.06; 0.00	0.116
SECONDARY Change in CSF IL-8 Cytokine Levels Between Drug vs Placebo Treated Patients	130.11; 153.43; -2.7; 0.54	0.569
SECONDARY Change in CSF MCP-1 Cytokine Levels Between Drug vs Placebo Treated Patients	-114.39; -116.75; -17.69; -4.62	0.498
SECONDARY Change in CSF G-CSF Cytokine Levels Between Drug vs Placebo Treated Patients	2.46; 3.3; 0.22; -0.23	0.177
SECONDARY Change in Cognitive Change Index (CCI) Between Drug vs Placebo Treated Patients	0.08; 0.06	0.803
SECONDARY Feasibility of Drug Administration as Measured by the Percentage of Doses Given Within the Correct Time Window	94.6; 93.8	—
SECONDARY Number of Participants Who Experience Delirium	26; 13	0.286
SECONDARY Peak Severity of Delirium Symptoms Between Drug vs. Placebo Treated Patients	1; 2	0.189

Summary

This research study will evaluate the effectiveness and estimate the feasibility of administering an investigational drug called 'CN-105' (the study drug), to prevent postoperative cognitive decline, delirium (serious confusion) and underlying brain inflammatory and brain activity changes in adults 60 years and older undergoing surgery.

Eligibility Criteria

Inclusion Criteria

Age ≥ 60
Ability to speak English
Undergoing non-cardiac, non-neurologic surgical procedures; surgery scheduled to last > 2 hours; due to be admitted to the hospital following surgery

Exclusion Criteria

Inmate of a correctional facility
Scheduled to receive systemic chemotherapy between the time of the two cognitive testing sessions
Known inability to undergo LPs due to anticoagulant use, severe anxiety, or other clinical contraindication known ahead of time.
Inappropriate for study inclusion based on the judgement of the principal investigator.
If a patient undergoes major head trauma that occurs between the times of the two cognitive testing sessions, then they will be withdrawn from the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03802396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.