This trial is active, not recruiting.

Conditions postoperative cognitive dysfunction, mild cognitive impairment
Sponsor New York University School of Medicine
Start date December 2008
End date July 2016
Trial size 41 participants
Trial identifier NCT00850928, H08-658


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
65 years and older scheduled for spine surgery will be undergoing serial assessments preoperatively and postoperatively over 6 time-points.

Primary Outcomes

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

To determine whether major surgery induces an increase in plasma Aβ40 and Aβ42.
time frame: 2 years
To determine whether the pattern of plasma inflammatory markers is different in patients with MCI compared to patients without MCI.
time frame: 2 years
To determine whether the Apolipoprotein E genotype correlates with POCD.
time frame: 2 years
To examine the relationship between plasma levels of Aβ40 / Aβ42 and subject performance on neurocognitive testing.
time frame: 2 years
To establish a correlation between preoperative mild cognitive impaired (MCI) and post operative cognitive decline ( POCD) using neurocognitive testing.
time frame: 2 years

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: 1. Patients age 65 and older scheduled to undergo spine surgery. 2. Subjects who are able to read and understand English Exclusion Criteria: 1. Emergent nature of the procedure which might preclude the conduct of preoperative cognitive examination 2. Participation in any other investigational intervention or clinical study 3. History of psychiatric illnesses (except depression)

Additional Information

Official title Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.