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CN-105 for Delirium (MARBLE Trial)

Phase 2
Waitlist Available
Led By Miles Berger, MD, PhD
Research Sponsored by Miles Berger, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years for entire study; until 6 week follow-up for individual patients
Awards & highlights

MARBLE Trial Summary

This trial will test whether the drug CN-105 can prevent postoperative cognitive decline, delirium, and brain inflammation in adults 60 and older.

Eligible Conditions
  • Delirium
  • Postoperative Cognitive Dysfunction

MARBLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years for entire study; until 6 week follow-up for individual patients
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for entire study; until 6 week follow-up for individual patients for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events (AEs) of grade II or higher, per CTCAE criteria
Secondary outcome measures
Change in CSF G-CSF cytokine levels between drug vs placebo treated patients
Change in CSF IL-8 cytokine levels between drug vs placebo treated patients
Change in CSF MCP-1 cytokine levels between drug vs placebo treated patients
+5 more

MARBLE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CN-105Experimental Treatment1 Intervention
Cohort 1: 67 Patients Dose of CN-105: 0.1 mg/kg Patients receiving drug: 50 Patients receiving placebo: 17 Cohort 2: 67 Patients Dose of CN-105: 0.5 mg/kg Patients receiving drug: 50 Patients receiving placebo: 17 Cohort 3: 67 Patients Dose of CN-105: 1 mg/kg Patients receiving drug: 50 Patients receiving placebo: 17
Group II: PlaceboPlacebo Group1 Intervention
Cohort 1: 67 Patients Dose of CN-105: 0.1 mg/kg Patients receiving drug: 50 Patients receiving placebo: 17 Cohort 2: 67 Patients Dose of CN-105: 0.5 mg/kg Patients receiving drug: 50 Patients receiving placebo: 17 Cohort 3: 67 Patients Dose of CN-105: 1 mg/kg Patients receiving drug: 50 Patients receiving placebo: 17
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CN-105
2017
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Miles Berger, MD PhDLead Sponsor
Miles Berger, MD, PhDPrincipal Investigator - Duke University
Duke University
4 Previous Clinical Trials
503 Total Patients Enrolled
2 Trials studying Delirium
392 Patients Enrolled for Delirium
~30 spots leftby Jun 2025
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