Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids
Postoperative Cognitive Dysfunction
Mild Cognitive Impairment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids.|
- 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 ] [ Designated as safety issue: No ]
- To determine whether major surgery induces an increase in plasma Aβ40 and Aβ42. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine whether the pattern of plasma inflammatory markers is different in patients with MCI compared to patients without MCI. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To determine whether the Apolipoprotein E genotype correlates with POCD. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To examine the relationship between plasma levels of Aβ40 / Aβ42 and subject performance on neurocognitive testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To establish a correlation between preoperative mild cognitive impaired (MCI) and post operative cognitive decline ( POCD) using neurocognitive testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||December 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
65 years and older scheduled for spine surgery will be undergoing serial assessments preoperatively and postoperatively over 6 time-points.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850928
|United States, New York|
|NYU School of Medicine|
|New York City, New York, United States, 10016|
|Study Director:||Germaine Cuff, PhD||NYU School of Medicine|