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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years for entire study; until 6 week follow-up for individual patients

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CN-105

2017

Completed Phase 2

~290

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative currently recruiting participants?

"Correct. According to clinicaltrials.gov, this medical study is still searching for participants since its initial post on July 15th 2018 and most recent update on August 23rd 2022. A total of 201 patients are required from a single site."

Answered by AI

How many participants are currently being recruited for this research trial?

"Affirmative. According to the information on clinicaltrials.gov, this trial is recruiting volunteers at present. It was initially posted on July 15th 2018 and updated most recently on August 23rd 2022. The study requires 201 participants from a single site."

Answered by AI

Has the FDA sanctioned CN-105?

"Due to the fact that CN-105 has only been subject to Phase 2 trials, it was assigned a score of two in terms of safety. This rating is based on evidence indicating some degree of security but no data confirming its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Miles Berger, MD PhD 2018. "Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03802396.