Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00850928|
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : March 17, 2016
|Condition or disease|
|Postoperative Cognitive Dysfunction Mild Cognitive Impairment|
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.
|Study Type :||Observational|
|Actual Enrollment :||41 participants|
|Official Title:||Postoperative Cognitive Decline, Inflammation, and Plasma Levels of Beta-amyloids.|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
65 years and older scheduled for spine surgery will be undergoing serial assessments preoperatively and postoperatively over 6 time-points.
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|