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Identifying Novel Aging Targets for Treatment of Delirium (INNOVATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03682874
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : April 22, 2019
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
The long-term goal of this research program is to improve understanding of the mechanistic link between Alzheimer's disease (AD) neuropathology, acute delirium, and cognitive impairment following acute respiratory failure. In this pilot study, the study team will establish a prospective cohort of older patients with acute respiratory failure and obtain data on delirium duration, AD imaging and CSF biomarkers, and cognitive outcomes following critical illness.

Condition or disease
Delirium Dementia Alzheimers Respiratory Failure

Detailed Description:
The study team will recruit patients with no known history of dementia for enrollment into the cohort during their hospital stay for acute respiratory failure. The cohort will undergo testing including cognitive testing, MRI imaging, lumbar puncture for cerebrospinal fluid (CSF) analysis at 3 months following hospital discharge. The study will examine the association of delirium duration during the hospital stay and cognitive impairment at 3 month follow-up with CSF levels of amyloid- β42, tau, and phospho-tau. Measures of delirium will also be related with structural/functional MRI dependent measures. The goal is to design a larger prospective cohort study to evaluate the relationship between AD imaging and CSF biomarkers with delirium and post-ICU cognitive impairment. The results of this pilot study with provide important information with regard to future study design including: (1) ratio of eligible to recruited patients (2) retention rate; (3) safety and feasibility of protocol; and (4) preliminary effect size estimates.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Novel Aging Targets for Treatment of Delirium
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Primary Outcome Measures :
  1. CSF biomarker [ Time Frame: 2-5 months after hospital discharge ]
    ratio of CSF AB42 to ptau

Secondary Outcome Measures :
  1. Structural/functional MRI dependent measures [ Time Frame: 2-5 months after hospital discharge ]
    gray matter volume

  2. Structural/functional MRI dependent measures [ Time Frame: 2-5 months after hospital discharge ]
    cerebral blood flow

Biospecimen Retention:   Samples With DNA
Plasma CSF

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We propose to recruit older patients with acute respiratory failure requiring mechanical ventilation admitted to the medical ICU of an academic medical center, Wake Forest Baptist Hospital.

Inclusion Criteria:

  • Age greater than or equal to 55 years
  • Anticipated ICU stay of at least 48 hours
  • Delirium during ICU stay defined as CAM-ICU positive on at least two occasions at least 12 hours apart within 72 hours.

Exclusion Criteria:

  • Diagnosis of dementia in electronic medical record at time of ICU admission
  • Blindness, deafness, or inability to understand English as this prevents ICU delirium assessment
  • Cognitive impairment prior to hospitalization (inability to follow instructions/comply with study/sign consent)
  • Score of > 3.30 on Informant Questionnaire of Cognitive -Decline in the Elderly (IQCODE)[34]. Questionnaire will be given to family member or legally authorized representative.
  • Pregnancy/lactating/breastfeeding
  • Legally incapacitated: Prisoner/Ward of State
  • Large Vessel CVAs (cerebrovascular accidents)
  • History of neurologic disorder prior to ICU admission including multiple sclerosis, Parkinson disease, epilepsy, amyotrophic lateral sclerosis (ALS), Guillain-Barre Syndrome (GBS)
  • Psychiatric illness including schizophrenia, bipolar disorder, depression with psychotic features
  • End stage renal disease requiring hemodialysis prior to admission
  • History of cirrhosis prior to admission
  • Chronic anticoagulation at the time of ICU admission. If patient is taking anticoagulation at the time of follow-up visit for lumbar puncture, the lumbar puncture will not be performed.
  • Coagulation disorder prior to admission resulting in chronic thrombocytopenia (platelet count < 100,000 mcL) or blood clotting disorder
  • Not expected to survive 24 hours
  • Judgment of investigator that subject participation could jeopardize subject health/safety or integrity of study
  • Active malignancy requiring treatment in the prior 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03682874

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Contact: Lori Flores, MD 336 713 0008
Contact: Jessica Palakshappa, MD 336 716 8465

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United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Lori Flores         
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: Jessica A Palakshappa, MD Wake Forest

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Responsible Party: Wake Forest University Health Sciences Identifier: NCT03682874     History of Changes
Other Study ID Numbers: IRB00052417
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Brain Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Respiratory Insufficiency
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms