Trial record 9 of 343 for:    Open Studies | "Alzheimer Disease"

Differential Effects of Various Anesthetic Agents on Cognitive Function in Patients With Alzheimer's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Zhongcong Xie, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01870453
First received: June 3, 2013
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

The objective of the study is to determine the effects of different anesthetic agents on cognitive function in patients with Alzheimer's disease (AD). The investigators will test the hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients with AD.


Condition
Alzheimer Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differential Effects of Various Anesthetic Agents on Cognitive Function in Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Cognitive Function [ Time Frame: 1 week pre-operatively to 1 year post-operatively ] [ Designated as safety issue: No ]
    Cognitive function will be assessed using a battery of neuropsychological tests in the domains of attention and executive functions (Trail Making Test, Verbal Fluency Test, Category Switching Test, Symbol Digit Modalities Test), memory (Hopkins Verbal Learning Test-R, Brief Visual Memory Test-R), visuospatial functions (Benton Judgement of Line Orientation Test), and language (Category Fluency Test).


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Isoflurane Anesthesia
Recruited subjects that were anesthetized with isoflurane for their surgery.
Sevoflurane Anesthesia
Recruited subjects that were anesthetized with sevoflurane for their surgery.
Desflurane Anesthesia
Recruited subjects that were anesthetized with desflurane for their surgery.
Propofol Anesthesia
Recruited subjects that were anesthetized with propofol for their surgery.

Detailed Description:

Patients with mild-to-moderate Alzheimer's disease who are scheduled to have elective noncardiac, nonneurologic, nonvascular surgery will be recruited at the Massachusetts General Hospital (MGH). The study will first be introduced to patients at their preoperative surgical clinic appointment by his/her surgeon. If patients are interested in participating, they will notify their surgeons, and subsequent recruitment will take place at the MGH Pre-Admission Testing Area (PATA), a clinic for preoperative evaluation and medical optimization. Patient contact and recruitment, however, will only proceed with permission from (1) the patient him/herself and (2) the patient's surgeon. Per the Partners Human Research Committees-approved criteria, if patients do not have capacity for clinical-decision making but express a willingness to participate in the study, a surrogate (i.e. healthcare proxy and/or family member) co-signature will be required on the consent form. On the day of the subject's surgery, the anesthesia team will be allowed to choose one of four anesthetic options (i.e. propofol anesthesia, isoflurane anesthesia, sevoflurane anesthesia, or desflurane anesthesia) based on clinical preference and appropriateness. The research team will be blinded to the anesthetic to which subjects are assigned. Finally, patients will be followed for one year post-operatively with a battery of cognitive tests to determine differences in cognitive trajectory.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

100 study participants with mild-to-moderate AD who are scheduled to have elective noncardiac, nonneurologic, nonvascular surgery will be recruited at MGH. Surgeons will first introduce the study to patients at their preoperative surgical clinic visit. If a patient expresses interest in the study, and with permission of the surgeon, the patient will then be contacted by study staff at his/her PATA preoperative evaluation and medical optimization clinic visit. Recruitment, screening, and enrollment will then occur at the patient's PATA clinic visit.

Criteria

Inclusion Criteria:

  • Patients diagnosed with Alzheimer's disease (AD) per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
  • Patient recruitment permission granted by his/her surgeon
  • Requires general anesthesia for elective noncardiac, nonneurologic, nonvascular surgery.

Exclusion Criteria:

  • History of neurologic or psychiatric disease (i.e. stroke, psychosis, etc.)
  • Non-native English speaker
  • Severe visual or auditory disorder
  • Sensitivity to sulfites (some propofol formulations at MGH may contain sodium metasulfite).
  • Asthma (sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870453

Contacts
Contact: Zhongcong Xie, MD, PhD 617-724-9308 zxie@partners.org
Contact: Phillip E Vlisides, MD 617-726-3030 pvlisides@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Zhongcong Xie, MD, PhD    617-724-9308    zxie@partners.org   
Contact: Phillip E Vlisides, MD    617-726-3030    pvlisides@partners.org   
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Zhongcong Xie, MD, PhD    617-724-9308    zxie@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Alzheimer's Association
  More Information

No publications provided

Responsible Party: Zhongcong Xie, Associate Professor of Anaesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01870453     History of Changes
Other Study ID Numbers: MassGH-001, HAT-12-237963
Study First Received: June 3, 2013
Last Updated: February 6, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Alzheimer Disease
Dementia
Postoperative Care
Cognitive Reserve

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014