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.
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
DeliriumDementia AlzheimersRespiratory Failure
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
55 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
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). Questionnaire will be given to family member or legally authorized representative.
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