A Phase 2 interventional study of CN-105 and Placebo in Postoperative Delirium and Postoperative Cognitive Dysfunction, sponsored by Miles Berger, MD PhD. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Miles Berger, MD PhD · Phase 2, Interventional, and Prevention
Among 81 studies in Emergence Delirium with a site in United States — 19 open to participants now, 20 under way, 2 of them phase 3. Emergence Delirium · United States.
Among the 81 studies in Emergence Delirium with a site in United States, this one is the 21st largest by enrollment of the 65 interventional ones that give a count, is one of 6 that started in 2018, is one of 8 in phase 2, and was the 38th registered.
752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →19 of the 81 studies in Emergence Delirium with a site in United States are open now. Recruiting first, the newest first:
University of Pittsburgh · Sites in United States
Ages 65+
Boston Children's Hospital · Sites in United States
Ages 1–12
The Methodist Hospital Research Institute · Sites in United States
Ages up to 65
Northwestern University · Sites in United States
Ages 18+
University of Chicago · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.
This study: 60 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 11 · Phase 3 10 · Phase 4 13
First in 2002; this study’s year is marked. 6 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 203 is above the median of 120 across 466 interventional studies indexed under Emergence Delirium.
Median enrollment 100 across the 65 interventional studies, 217 across the 16 observational. Of the 59 that completed or were terminated, 33 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 81 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Miles Berger, MD PhD as lead sponsor.
Miles Berger, MD PhD has 1 study filed under Emergence Delirium — fewer than ten, so there is no comparison to draw.
9 of the studies in Emergence Delirium with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06133842Beth Israel Deaconess Medical CenterCEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State | 2026-12 |
| NCT06324955Boston Children's HospitalLanguage During Inhalational Induction | 2027-03 |
| NCT06036095Oregon Health and Science UniversityTotal Intravenous Versus Inhalational Anesthesia- A Geriatric Anesthesia Study | 2027-03-15 |
| NCT07933003Stanford UniversityPrehab-COG: Does Preoperative Exercise Improve Postoperative Cognitive Outcomes? | 2027-06 |
| NCT07672301University of ChicagoTotal Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty | 2027-06 |
Add all 9 to your calendar (.ics) → With an account.
Among the 81 studies in Emergence Delirium with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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. The word "investigational" means the study drug is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).
It is hoped that CN-105 will block signaling via a gene known as ApoE4, the most common gene implicated in late life Alzheimer's disease.
Depending on when patients enroll in this study, participants will receive either a placebo or a progressively higher dose of CN-105 until the safest and best tolerated dose is reached. The study drug is given via IV (intravenous, meaning through a vein) infusion in the hospital. Study drug infusions will be given up to 4 days after surgery.
Participants will also perform memory and thinking tests, as well as complete a survey and functional assessments, both prior to surgery and again 6 weeks after surgery. Each of those research visits will last about 1 hour.
Additionally, the investigators will collect a blood sample and a cerebrospinal fluid (CSF) sample prior to the participant's surgery, 24 hours after surgery, and again 6 weeks after surgery. To obtain the CSF (cerebrospinal fluid) sample, investigators will perform a lumbar (the lower part of the spinal column) puncture. During surgery, investigators will also record participant brain waves from the scalp using an EEG (electroencephalography) monitor. An electroencephalography monitor reads the electrical activity of the brain in different places using a cap with sensors that is worn on the head.
Although previous studies have not found any associations between the study drug and any serious medical problems, investigators will monitor its effect on wound healing and postoperative infections.
Benefits of this study include the possibility of fewer problems in thinking and memory after surgery if this study drug works as hoped.
Risks of participation in this study include headache, infection/discomfort from the lumbar puncture, discomfort from the blood draw, and minor skin irritation or redness from the EEG and heart rate monitor procedures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1: 50 Patients Dose of CN-105: 0.1 mg/kg Cohort 2: 50 Patients Dose of CN-105: 0.5 mg/kg Cohort 3: 50 Patients Dose of CN-105: 1 mg/kg
Drug: CN-105
Cohort 1: 17 Patients receiving placebo Cohort 2: 17 Patients receiving placebo Cohort 3: 17 Patients receiving placebo
Drug: Placebo
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.
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.
Number of Adverse Events (AEs) of Grade II or Higher Per Patient
Safety of CN-105 administration, as measured by adverse event (AE) rates of Grade II and higher in CN-105 versus placebo-treated patients.
Time frame: up to 6-week follow-up
Change in Cerebrospinal Fluid (CSF) IL-6 Cytokine Levels Between Drug vs Placebo Treated Patients
Change in CSF IL-6 cytokine levels from before to after surgery between drug vs placebo treated patients.
Time frame: Baseline, 24 hours, approximately 6 weeks
Change in CSF IL-8 Cytokine Levels Between Drug vs Placebo Treated Patients
Change in CSF IL-8 cytokine levels from before to after surgery between drug vs placebo treated patients
Time frame: Baseline, 24 hours, approximately 6 weeks
Change in CSF MCP-1 Cytokine Levels Between Drug vs Placebo Treated Patients
Change in CSF MCP-1 cytokine levels before to after surgery between drug vs placebo treated patients
Time frame: Baseline, 24 hours, approximately 6 weeks
Change in CSF G-CSF Cytokine Levels Between Drug vs Placebo Treated Patients
Change in CSF G-CSF cytokine levels before to after surgery between drug vs placebo treated patients.
Time frame: Baseline, 24 hours, approximately 6 weeks
Change in Cognitive Change Index (CCI) Between Drug vs Placebo Treated Patients
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a Z-score standardization was performed on the 11 cognitive test scores with mean and standard deviation derived at the baseline timepoint. We then constructed four summary scores by taking the average of the standardized cognitive test scores, which represent the following cognitive domains: verbal memory, executive function, visual memory and attention. To quantify overall cognitive function, a cognitive index was calculated as the mean of the 4 domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.33. A negative change score indicating decline and a positive score indicating improvement.
Time frame: Baseline, approximately 6 weeks
Feasibility of Drug Administration as Measured by the Percentage of Doses Given Within the Correct Time Window
The feasibility of perioperative CN-105 administration is assessed by tracking the percentage of doses given within the correct time window (i.e. within 1 hour prior to the scheduled or actual start time of the surgery, and within a +/- 90 minute time window for subsequent doses, which are administered every 6 hours after the start of surgery).
Time frame: admission to preoperative holding to hospital discharge (up to postoperative day 4)
Number of Participants Who Experience Delirium
Scores on 3D CAM (non-intubated patients) or CAM ICU (intubated patients) are used to determine whether patients have delirium (yes/no).
Time frame: Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeks
Peak Severity of Delirium Symptoms Between Drug vs. Placebo Treated Patients
Scores on the 3D CAM (in non-intubated patients) are used to determine delirium symptom severity based on a 0 - 20 point scale of the test. Higher scores indicate worse delirium.
Time frame: Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeks
| Milestone | CN-105 | Placebo |
|---|---|---|
| Started | 140 | 49 |
| Completed | 137 | 49 |
| Not completed | 3 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Surgery cancelled | 1 | 0 |
Safety of CN-105 administration, as measured by adverse event (AE) rates of Grade II and higher in CN-105 versus placebo-treated patients.
| events per participant | CN-105 | Placebo |
|---|---|---|
| Number of Adverse Events (AEs) of Grade II or Higher Per Patient | 1 (1 to 3) | 2 (1 to 5) |
Change in CSF IL-6 cytokine levels from before to after surgery between drug vs placebo treated patients.
| pg/mL | CN-105 | Placebo |
|---|---|---|
| Baseline to 24 hours | 0.52 (-0.08 to 1.35) | 0.91 (0.30 to 1.63) |
| Baseline to 6 weeks | -0.06 (-0.40 to 0.17) | 0.00 (-0.20 to 0.12) |
Change in CSF IL-8 cytokine levels from before to after surgery between drug vs placebo treated patients
| pg/mL | CN-105 | Placebo |
|---|---|---|
| Baseline to 24 hours | 130.11 (69.11 to 227.90) | 153.43 (67.44 to 268.26) |
| Baseline to 6 weeks | -2.7 (-8.06 to 0.32) | 0.54 (-4.23 to 4.08) |
Change in CSF MCP-1 cytokine levels before to after surgery between drug vs placebo treated patients
| pg/mL | CN-105 | Placebo |
|---|---|---|
| Baseline to 24 hours | -114.39 (-177.58 to -22.06) | -116.75 (-195.11 to -26.95) |
| Baseline to 6 weeks | -17.69 (-58.01 to 21.33) | -4.62 (-32.16 to 6.32) |
Change in CSF G-CSF cytokine levels before to after surgery between drug vs placebo treated patients.
| pg/mL | CN-105 | Placebo |
|---|---|---|
| Baseline to 24 hours | 2.46 (0.75 to 6.36) | 3.3 (1.89 to 10.18) |
| Baseline to 6 weeks | 0.22 (-1.10 to 1.13) | -0.23 (-0.96 to 0.77) |
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a Z-score standardization was performed on the 11 cognitive test scores with mean and standard deviation derived at the baseline timepoint. We then constructed four summary scores by taking the average of the standardized cognitive test scores, which represent the following cognitive domains: verbal memory, executive function, visual memory and attention. To quantify overall cognitive function, a cognitive index was calculated as the mean of the 4 domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.33. A negative change score indicating decline and a positive score indicating improvement.
| units on a scale | CN-105 | Placebo |
|---|---|---|
| Change in Cognitive Change Index (CCI) Between Drug vs Placebo Treated Patients | 0.08 ± 0.33 | 0.06 ± 0.34 |
The feasibility of perioperative CN-105 administration is assessed by tracking the percentage of doses given within the correct time window (i.e. within 1 hour prior to the scheduled or actual start time of the surgery, and within a +/- 90 minute time window for subsequent doses, which are administered every 6 hours after the start of surgery).
| percentage of doses | CN-105 | Placebo |
|---|---|---|
| Feasibility of Drug Administration as Measured by the Percentage of Doses Given Within the Correct Time Window | 94.6 (92.9 to 96.0) | 93.8 (90.8 to 96.0) |
Scores on 3D CAM (non-intubated patients) or CAM ICU (intubated patients) are used to determine whether patients have delirium (yes/no).
| Participants | CN-105 | Placebo |
|---|---|---|
| Number of Participants Who Experience Delirium | 26 | 13 |
Scores on the 3D CAM (in non-intubated patients) are used to determine delirium symptom severity based on a 0 - 20 point scale of the test. Higher scores indicate worse delirium.
| score on a scale | CN-105 | Placebo |
|---|---|---|
| Peak Severity of Delirium Symptoms Between Drug vs. Placebo Treated Patients | 1 (1 to 2) | 2 (1 to 2) |
Collected over Surgery to 6-week follow-up visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CN-105 | 0/137 (0%) | 11/137 (8%) | 105/137 (76.6%) |
| Placebo | 0/49 (0%) | 11/49 (22.4%) | 43/49 (87.8%) |
| Event | CN-105 | Placebo |
|---|---|---|
| ANEMIABlood and lymphatic system disorders | 1/137 | 3/49 |
| HYPOTENSIONVascular disorders | 1/137 | 3/49 |
| HYPOXIARespiratory, thoracic and mediastinal disorders | 0/137 | 2/49 |
| CONSTIPATIONGastrointestinal disorders | 0/137 | 1/49 |
| CYSTOSCOPY FOR REMOVAL OF URINARY CATHETERSurgical and medical procedures | 0/137 | 1/49 |
| FATIGUEGeneral disorders | 0/137 | 1/49 |
| GASTRIC STENOSISGastrointestinal disorders | 0/137 | 1/49 |
| HEMORRHAGEInjury, poisoning and procedural complications | 0/137 | 1/49 |
| HYPERTENSIONVascular disorders | 0/137 | 1/49 |
| HYPOXEMIARespiratory, thoracic and mediastinal disorders | 0/137 | 1/49 |
| Event | CN-105 | Placebo |
|---|---|---|
| HYPERTENSIONVascular disorders | 61/137 | 22/49 |
| DECREASED LYMPHOCYTE COUNTInvestigations | 27/137 | 15/49 |
| ANEMIABlood and lymphatic system disorders | 30/137 | 9/49 |
| INFECTIONInfections and infestations | 17/137 | 6/49 |
| HYPERGLYCEMIAMetabolism and nutrition disorders | 4/137 | 6/49 |
| DIZZINESSNervous system disorders | 3/137 | 5/49 |
| VOMITINGGastrointestinal disorders | 5/137 | 5/49 |
| HYPOTENSIONVascular disorders | 12/137 | 3/49 |
| HYPOALBUMINEMIAMetabolism and nutrition disorders | 11/137 | 4/49 |
| NAUSEAGastrointestinal disorders | 6/137 | 4/49 |
Participants who completed the study.
| Age, Continuous(years) | CN-105 | Placebo | Total |
|---|---|---|---|
| Mean | 68.4 ± 5.0 | 69.5 ± 6.0 | 68.7 ± 5.0 |
| Sex: Female, Male(Participants) | CN-105 | Placebo | Total |
|---|---|---|---|
| Female | 51 | 16 | 67 |
| Male | 86 | 33 | 119 |
| Ethnicity (NIH/OMB)(Participants) | CN-105 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 135 | 47 | 182 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | CN-105 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 5 | 14 |
| White | 122 | 42 | 164 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(Participants) | CN-105 | Placebo | Total |
|---|---|---|---|
| United States | 137 | 49 | 186 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Dec 2022, 53 months.
Results were first posted in Sep 2024, 1 year 8 months after primary completion. A results delay was requested in Oct 2023.
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Studies of the drug tested here: CN-105