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Identifying Novel Aging Targets for Treatment of Delirium

Identifying Novel Aging Targets for Treatment of Delirium

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03682874
Acronym
INNOVATE
Enrollment
5
Registered
2018-09-25
Start date
2018-10-10
Completion date
2020-02-20
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Dementia Alzheimers, Respiratory Failure

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.

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.

Interventions

None listed

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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 * History of prior large vessel cerebrovascular accident (CVA) * 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 * 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 * Inability to return for study procedures * Inability to obtain consent

Design outcomes

Primary

MeasureTime frameDescription
Structural/functional MRI dependent measures2-5 months after hospital dischargegray matter volume

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026