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NCT Number: NCT00850928

Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids

Postoperative cognitive dysfunction (POCD) can be a serious complication. The development of therapeutic strategies for the prevention and treatment of this condition requires the identification of subgroup of patients with the greatest incidence of POCD. Several retrospective analyses have raised the possibility that surgery is a risk factor for the accelerated progression of Alzheimer's disease (AD). Moreover, there is increasing evidence that inflammatory mechanisms are involved in the pathogenesis of AD. Major surgery can be associated with a profound systemic inflammatory response. Consequently, it is reasonable to suggest that there is a link between major surgery and the postoperative development of AD in patients who are already at high risk for this complication, e.g. the elderly with mild cognitive impairment. In addition, there are several laboratory investigations that suggest that anesthetic agents increase amyloid peptide levels as well as enhance oligomerization of these proteins. The significance of these findings, however, is unknown. This clinical study seeks to correlate perioperative inflammatory responses, perioperative changes in amyloid-beta protein levels (markers of AD) with neurocognitive and functional outcome in the elderly who are at risk for POCD. This knowledge does not exist, but is essential in the effort to plan perioperative care that can reduce the incidence of POCD as well as improve functional recovery.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU School of Medicine

New York, 10016, United States

About this study

We will recruit 50 patients 65 years and older scheduled for spine surgery. The design utilizes prospective serial assessments. The enrolled 50 surgical subjects will be evaluated preoperatively and postoperatively over 6 time-points (preoperatively, inta-op, post op day 1, post op day 7, three months and six months) using a widely accepted set of neurocognitive tests, multiple indices of functional recovery, as well as blood tests for plasma biomarkers of inflammation and β-amyloids. Enrollees will be divided in 2 groups: 25 patients with mild cognitive impairment (diagnosed by clinical assessment) and 25 normal elderly patients.

The definition of normal elderly includes: 1). Global Deterioration Scale (GDS) < 3 and Mini-Mental Exam Score (MMSE) >27; 2). Performance on neurocognitive testing (including memory) that is within 1.5 Standard Deviation (SD) of the age matched normative data; 3). The informant interview confirming no functional impairment in the subject. The definition of MCI includes: self-reported memory and functional complains, a history of memory decline with functional changes that are corroborated by a knowledgeable informant, and a clinical interview resulting in a GDS=3 or higher and MMSE=26 or lower.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients age 65 and older scheduled to undergo spine surgery.
  • Subjects who are able to read and understand English

Exclusion criteria

  • Emergent nature of the procedure which might preclude the conduct of preoperative cognitive examination
  • Participation in any other investigational intervention or clinical study
  • History of psychiatric illnesses (except depression)

Treatment and study plan

Primary outcomes

  1. To examine the effect of surgery on the progression of AD in a population at high risk for this disease through measures of Amyloid Beta levels (AB40 and AB42). levels

    Time frame: 2 years

Secondary outcomes

  1. To determine whether major surgery induces an increase in plasma Aβ40 and Aβ42.

    Time frame: 2 years

  2. To determine whether the pattern of plasma inflammatory markers is different in patients with MCI compared to patients without MCI.

    Time frame: 2 years

  3. To determine whether the Apolipoprotein E genotype correlates with POCD.

    Time frame: 2 years

  4. To examine the relationship between plasma levels of Aβ40 / Aβ42 and subject performance on neurocognitive testing.

    Time frame: 2 years

  5. To establish a correlation between preoperative mild cognitive impaired (MCI) and post operative cognitive decline ( POCD) using neurocognitive testing.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2009
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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