ClinicalTrials.gg
Status unknownNCT03393130PRIMoGenITAUpdated Jan 8, 2018

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

An observational study in Cognitive Impairment, Apolipoprotein E, Deficiency or Defect of and Critical Illness, sponsored by Chelsea and Westminster NHS Foundation Trust. Status unknown. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by Chelsea and Westminster NHS Foundation Trust · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 25 Years
Sex
All
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Study 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.

Read the detailed description

Long-lasting post-operative cognitive dysfunction (POCD) is now a well-recognised complication of surgery, anaesthesia and critical care. It has been shown that cognitive impairment in critical care survivors can be worse than cohorts diagnosed with Mild Cognitive Impairment and approaching those suffered moderate Traumatic Brain Injury. POCD most significantly impacts upon the elderly, comorbid and those with pre-existing cognitive impairment, and has a socially and psychologically significant impact on quality of life.

The current central dogma suggests an underlying neuroinflammatory dysregulation affecting neuronal function. However, the underlying pathological processes have not yet been fully elucidated. Although some risk factors have been recognised we cannot accurately predict outcome, suggesting other unidentified determinants. The discovery of further risk factors would allow new insights into the underlying mechanism, and open up future avenues of investigation and potential interventions.

Thus far, little work has been performed looking into the impact of genomics on cognitive outcome after critical care. There are an estimated 20,000 protein coding genes in the human genome. Such large numbers of whole exome sequence variables necessitate using either an extremely large population or testing a small number of candidate genes. Critical Care research is hampered by small population sizes, ruling out whole genome analysis. The ideal candidate gene would be a known modulator of neuroinflammation, synthesised in the central nervous system (or able to traverse the blood-brain barrier) and have a known association with cognitive impairment. In terms of feasibility it should have relatively high incidence allele proportions, and be modifiable for in order to test any association for causality.

The most common gene associated with cognitive impairment is APOE, which codes for apolipoprotein E (ApoE). There are three common alleles of the APOE gene: APOE-∈2, APOE-∈3 and APOE-∈4. Possession of an APOE-∈4 allele increases the risk of developing late-onset Alzheimer's Disease. ApoE demonstrates immunomodulatory properties both systemically and in the central nervous system. It is secreted by astrocytes and oligodendrocytes after brain injury and is implicated in the cholesterol distribution necessary for membrane growth after axonal injury. ApoE-deficient murine glial cultures express more nitric oxide (NO) and Tissue Necrosis Factor α (TNFα) after simulated injury (LPS / closed head injury) than wild-type cells. Incubating the deficient glial cultures in recombinant apoE suppresses the TNF-α expression. This suppression occurred to a much greater extent with recombinant apoE-∈3 and apoE-∈2 than with apoE-∈4. Finally, microglia treated with secreted amyloid precursor protein α (sAPP-α, a secreted derivative of β amyloid precursor protein (β-APP)) will produce higher levels of activation markers and enhance the production of neurotoxins. This effect can be blocked by prior incubation apoE3, but not with apoE4. Administration of peripheral ApoE mimetic peptide (a truncated protein able to traverse the blood brain barrier) suppresses systemic and brain Il-6 and TNFα levels. Lastly, ApoE isoforms also have different affects on cholinergic neuron destruction, through increased synthesis and reduced elimination of amyloid beta.

Critical care patients typically experience systemic inflammation secondary to sepsis, surgery or trauma, or a combination of the three. Central nervous system (CNS) ApoE mRNA expression is upregulated in wild-type mice exposed to repeated restraint stress. As such, it is possible that APOE genotype may influence cognitive outcome through mediation of the neuroinflammatory response. The APOE-∈4 allele is known to increase the risk of POD after surgery and to increase the duration of delirium in the intensive care unit (ITU). The presence and duration of post-operative delirium (POD) are recognised predictors of long-term cognitive impairment (LTCI). Neither the incidence of delirium nor LTCI according to APOE genotype have been investigated in critical care patients.

More recently, burns intensive care (BICU) survivors have also been shown to develop LTCI following discharge with an associated reduction in quality of life.

The incidence of cognitive impairment amongst severe burns patients is comparable to ARDS cohorts, but in a younger and less comorbid group. Patients with severe burns develop large magnitude systemic inflammatory reactions secondary to their injury. This is perpetuated by multiple surgeries and a high incidence of nosocomial infections. This cohort provides a unique group of relatively young individuals with comparable injuries and minimal pre-morbid comorbidity or cognitive impairment. As such, they represent a less varied population than general adult ITUs. It is also unusual to find evidence of AD, vascular dementia or Parkinson's dementia in younger age brackets. This reduces the confounding factors that typically impede critical care clinical research and any association between APOE-∈4 and ITU LTCI may therefore infer a common pathological process.

We hypothesise that severe burn patients who possess an APOE ε4 allele are more susceptible to long term cognitive impairment following their injuries, and that this will impact significantly on their quality of life.

With this study we aim to: assess neurocognitive function following a severe burn; more specifically processing speed, executive function, working memory, immediate recall and delayed recall; assess our sample population APOE genotype; and investigate the association between APOE genotype and cognitive function.

02

Conditions studied

  • 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
03

In context

Cognitive Dysfunction

3,875 studies on the registry are indexed under Cognitive Dysfunction; 1,121 are open to participants now.

This study's planned enrollment of 150 is close to the median of 150 across 998 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testAPOE genotyping

    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

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What researchers measure

Primary outcomes

  1. APOE genotype

    Possession of an APOE-ε4 allele

    Time frame: Twelve month recruitment window

Secondary outcomes

  1. Cognitive impairment

    Above or below the median cognitive score

    Time frame: Twelve month recruitment window

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

    Estimate of premorbid cognitive function (confounder)

    Time frame: Twelve month

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

    Substance misuse index

    Time frame: Twelve month

  4. Health Utilities Index 3 (HUI-3) score

    Quality of life index

    Time frame: Twelve month

  5. Patient Health Questionnaire 9 (PHQ-9) score

    Depression index

    Time frame: Twelve month

  6. Generalised Anxiety Disorder 7 (GAD 7) score

    Anxiety index

    Time frame: Twelve month

  7. Trauma Screening Questionnaire (TSQ) score

    Post-traumatic stress index

    Time frame: Twelve month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2018; primary completion for Feb 2019, 12 months later.

Of 504 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 118. This study's planned 12 months is below that.

Counting every sponsor, half of 543 studies reached it within 47 months; a quarter within 21 and three quarters within 118.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Jan 8, 2018
StartEst.
Feb 1, 2018
Primary completionEst.
Feb 1, 2019
CompletionEst.
Dec 1, 2019
Last update
Jan 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03393130
Lead sponsor
Chelsea and Westminster NHS Foundation Trust
Responsible party
Marcela P. Vizcaychipi (Principle Investigator, Chelsea and Westminster NHS Foundation Trust) — Principal investigator
First posted
Jan 8, 2018
Start date
Feb 1, 2018 (estimated)
Primary completion
Feb 1, 2019 (estimated)
Completion
Dec 1, 2019 (estimated)
Last update
Jan 8, 2018

Study contacts

Edward JR Watson, BMBS
Contact
edward.watson@chelwest.nhs.uk
(+44)7815 946 461
Marcela P Vizcaychipi, MD PhD
Contact
m.vizcaychipi@imperial.ac.uk
+44 20 3215 8024
Marcela P Vizcaychipi, MD PhD
principal investigator · Chelsea and Westminster NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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