Phase 2
Completed N=189
Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction
Source: ClinicalTrials.gov NCT03802396 ↗Enrolled (actual)
189
Serious AEs
11.8%
Results posted
Sep 2024
Primary outcomePrimary: Number of Adverse Events (AEs) of Grade II or Higher Per Patient — 1; 2 events per participant — p=0.025
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.
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 |
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.
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. Informational only — not medical advice.