Mild Cognitive Impairment Clinical Trial
— CognigramOfficial title:
Assessing Postoperative Cognitive Changes After Major Joint Arthroplasty: A Feasibility Study Using the CogState Brief Battery
Verified date | May 2017 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients assume that cognitive performance rapidly returns to baseline after anesthesia and surgery. Several studies have shown that one week after major non-cardiac surgery about 27% of patients have postoperative cognitive dysfunction (POCD) and 10% of patients at 3 months. Very few studies have assessed the incidence of POCD beyond 3 months. POCD significantly reduces quality of life. Identifying risk factors for POCD is important because it is associated with prolonged hospital stay, loss of independence, and premature retirement. There is an urgent need to measure and document the level of cognitive change associated with surgery with an easy to use tool, both prior to admission and after discharge. This information can be used to plan appropriate care paths and to identify or test the efficacy of potential new treatments to alter the negative trajectory.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 1, 2017 |
Est. primary completion date | May 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: • All patients = 50 years of age undergoing elective total hip or knee arthroplasty at Sunnybrook Health Sciences Centre Exclusion Criteria: - Lack of informed consent - Inability to comply with study procedures or follow-up visits - Patients with diagnosed dementia or those being treated with donepezil (Aricept®) - Patients with severe cognitive impairment defined as baseline with a CBB score of equal to or less than 80 in at least one of the 4 CBB domains - Patients with psychiatric diagnoses including schizophrenia, bipolar disorder, major depressive mood disorder - Patients undergoing a second joint replacement & previously enrolled in this study within the past 6 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Dr. Stephen Choi |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery | Change in Cognitive Brief Battery (CBB) score from baseline to 4.5 months after surgery | 4.5 months after surgery | |
Secondary | Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80) | Proportion of patients developing severe cognitive dysfunction at 4.5 months after surgery (defined as CBB score less than 80) | 4.5 months after surgery | |
Secondary | Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90 | Proportion of patients developing mild cognitive impairment at 4.5 months after surgery defined as CBB score between 81 and 90 | 4.5 months after surgery | |
Secondary | The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months | The effect of pre-operative mild cognitive impairment, pre-operative chronic inflammatory states, postoperative delirium, and postoperative complications on the incidence of mild cognitive impairment and severe cognitive dysfunction at 4.5 months | 4.5 months after surgery |
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