Mild Cognitive Impairment Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | NYU School of Medicine | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 years | No | |
Secondary | To determine whether major surgery induces an increase in plasma Aß40 and Aß42. | 2 years | No | |
Secondary | To determine whether the pattern of plasma inflammatory markers is different in patients with MCI compared to patients without MCI. | 2 years | No | |
Secondary | To determine whether the Apolipoprotein E genotype correlates with POCD. | 2 years | No | |
Secondary | To examine the relationship between plasma levels of Aß40 / Aß42 and subject performance on neurocognitive testing. | 2 years | No | |
Secondary | To establish a correlation between preoperative mild cognitive impaired (MCI) and post operative cognitive decline ( POCD) using neurocognitive testing. | 2 years | No |
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