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



Status:Completed
Conditions:Cognitive Studies, Hospital
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:65 - Any
Updated:4/21/2016
Start Date:December 2008
End Date:January 2011

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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.

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.

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)
We found this trial at
1
site
227 East 30th Street
New York City, New York 10016
?
mi
from
New York City, NY
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