Perioperative Research Into Memory, Genomics in the Intensive Therapy Unit: Alzheimer's

NCT03393130 | Unknown

• 1 other identifier: C&W17/059
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current central dogma of long-term cognitive impairment after intensive care admission suggests an underlying neuroinflammatory dysregulation affecting neuronal function. This pathological process has not been fully elucidated and there has been little research into its genetic associations. Alzheimer's disease (AD) causes cognitive impairment through a process of abnormal beta amyloid deposition and neuronal death through localised activation of the innate immune system. It is the most prevalent disease affecting cognition. The Apolipoprotein E (APOE) gene is implicated in the progression of late-onset Alzheimer's disease and is a recognised neuroinflammatory modulator. It is possible that young individuals exposed to high levels of inflammation may experience an acceleration of this process. This study sets out to look for an association between APOE-∈4 possession and poor cognitive outcome after a major burn injury and intensive care admission.

Conditions

Cognitive Impairment; Apolipoprotein E, Deficiency or Defect of; Critical Illness; Burns; Young Adult

Keywords

Burns; Young Adult; Cognitive Impairment; Apolipoprotein E, Deficiency or Defect of; Intensive Care Neurological Disorder; Quality of Life; Inflammation, Brain

Outcome Measures

Primary Outcomes (1)

• APOE genotype

  Possession of an APOE-ε4 allele

  Twelve month recruitment window

Secondary Outcomes (7)

• Cognitive impairment

  Twelve month recruitment window

• Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly score

  Twelve month

• Adapted American Psychiatric Association National Institute on Drug Abuse Modified Alcohol, Smoking and Substance Involvement Screening Test (APA NM-ASSIST)

  Twelve month

• Health Utilities Index 3 (HUI-3) score

  Twelve month

• Patient Health Questionnaire 9 (PHQ-9) score

  Twelve month

Study Arms (2)

Participants possessing APOE-ε4

Young adults who have suffered a severe burn injury necessitating intensive care admission 5 to 10 years previously, who possess at least one copy of the APOE-ε4 allele.

Diagnostic Test: APOE genotyping

Participants not possessing APOE-ε4

Young adults who have suffered a severe burn injury necessitating intensive care admission 5 to 10 years previously, who do not possess a copy of the APOE-ε4 allele.

Diagnostic Test: APOE genotyping

Interventions

APOE genotyping DIAGNOSTIC_TEST

APOE genotyping and broad cognitive assessment expressed as a median T-score of the following tests (with cognitive domains assessed in brackets) Trail Making Part A (processing speed), Trail Making Part B (executive function), One Back test (working memory), List Learning Task (Immediate recall, visual learning, delayed recall and recognition discrimination).

Also known as: Neurocognitive testing

Participants not possessing APOE-ε4; Participants possessing APOE-ε4

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Consenting young adults who suffered a severe burn injury necessitating intensive care admission 5-10 years previously.

You may qualify if:

• Consenting individual
• Burn injury \>15% total body surface area
• Admission to a Burns Intensive Care Unit between Jan 2007- Jan 2012
• Intubated and ventilated during the admission

You may not qualify if:

• Patients admitted to BICU with Toxic Epidermal Necrolysis Syndrome or Steven-Johnson Syndrome
• Head trauma
• Currently held under the 2007 Mental Health Act (UK) or Section 5150 of the California Welfare and Institutions Code (USA).
• Currently receiving formal psychiatric treatment (including involvement in a Personality Disorder Unit, being under voluntary section, current re-occurrence of chronic self-harm)
• Current imprisonment
• Current substance abuse (within two weeks of assessment)
• Patients unable to understand plain verbal and written English.

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab

MeSH Terms

Conditions

Cognitive Dysfunction; Apolipoprotein E, Deficiency or Defect of; Critical Illness; Burns; Encephalitis

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Marcela P Vizcaychipi, MD PhD

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward JR Watson, BMBS

CONTACT

(+44)7815 946 461; edward.watson@chelwest.nhs.uk

Marcela P Vizcaychipi, MD PhD

CONTACT

+44 20 3215 8024; m.vizcaychipi@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: January 8, 2018
• Study Start: February 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 8, 2018

Record last verified: 2018-01