Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cognitive Studies, Infectious Disease, Hospital, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 1/16/2019 |
| Start Date: | January 30, 2019 |
| End Date: | October 31, 2020 |
| Contact: | Donna M Crabtree, PhD |
| Email: | donna.crabtree@duke.edu |
| Phone: | 1-919-668-3389 |
Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction (MARBLE): A Phase 2 Trial to Evaluate the Efficacy and Feasibility of the Apolipoprotein E Mimetic Peptide, CN-105, in Preventing Postoperative Cognitive Dysfunction and Delirium and Blocking Their Underlying Neural Mechanisms
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.
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, they 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, we 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, we will perform a lumbar (the lower part of the spinal
column) puncture. During surgery, we will also record your brain waves from your 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, we 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.
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, they 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, we 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, we will perform a lumbar (the lower part of the spinal
column) puncture. During surgery, we will also record your brain waves from your 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, we 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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
