The 'Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia' (IMPACT-AD BC) study is an observational, longitudinal cohort study that will examine the impact of cerebrospinal fluid (CSF) testing for core Alzheimer's disease biomarkers on clinical decision making, diagnosis and health system utilization. In addition to data collection from physicians, the study will engage patients and their care partners in assessing the value of biomarker testing. IMPACT-AD BC investigators hypothesize that testing for CSF biomarkers of Alzheimer's disease in individuals with cognitive impairment, as part of routine clinical care, improves clinical management, diagnostic certainty, diagnostic accuracy, and healthcare resource utilization, and that patients and their care partners find the information valuable in planning for the future.
The IMPACT-AD BC study is an observational, longitudinal cohort study designed to understand the impact of cerebrospinal fluid (CSF) testing for core Alzheimer's disease biomarkers on clinical decision making, diagnosis, health system utilization, and patients and their care partners. Dementia specialists from multiple sites in the Canadian province of British Columbia will be approached to provide informed consent to participate. When these physicians order Alzheimer's disease CSF biomarker testing as part of routine care (DeMarco et al 2020), their patients will be eligible to participate in the study. Eligible patients (the patient participants) and their study partners (e.g., a family member or care partner) will be approached to provide informed consent to participate. The dementia specialists will provide diagnosis and management plans for their consenting patient participants before and after Alzheimer's disease CSF biomarker results. One year after release of the Alzheimer's disease CSF biomarker results, dementia specialists complete another questionnaire to assess the stability of their responses. In addition to these data, the study will collect patient participant/care partner perspectives on CSF biomarker testing post-results disclosure. Via the IMPACT-AD BC study, the investigators will collect the first data of its kind on the utility of CSF biomarkers in routine care in Canada, with the overall goal of improving care and support systems for individuals living with neurodegenerative disorders.
Study Type
OBSERVATIONAL
Enrollment
120
Measurement of amyloid beta peptide 1-42, amyloid beta peptide 1-40, and total tau in cerebrospinal fluid.
Northern Health
Prince George, British Columbia, Canada
Providence Health Care
Vancouver, British Columbia, Canada
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Island Health
Victoria, British Columbia, Canada
To assess the impact of Alzheimer's disease core CSF biomarker testing on the management of patients meeting the appropriate use criteria for lumbar puncture and testing.
Determine the percent change between intended management (without biomarkers) and actual patient management (with biomarkers) in a composite measure of at least one of the following: 1. Alzheimer's disease drug therapy; 2. Other relevant drug therapy; 3. Diagnostic procedure, imaging, other biofluid testing; 4. Referral or counselling.
Time frame: 12 months
To describe the participant's experience with Alzheimer's disease CSF biomarker testing.
Describe the participant's experience with Alzheimer's disease CSF biomarker testing and evaluate the impact of testing on their planning and decision-making via interviews one-month and six-months post-disclosure of CSF biomarker results.
Time frame: 6 months
To describe the study partner's experience with Alzheimer's disease CSF biomarker testing.
Describe the study partner's experience with Alzheimer's disease CSF biomarker testing and evaluate the impact of testing on their planning and decision-making via interviews one-month and six-months post-disclosure of CSF biomarker results.
Time frame: 6 months
To assess changes in participant management among various clinical presentations.
Describe the association of Alzheimer's disease CSF biomarker testing results with changes in management in individuals, from prodromal to dementia stage, presenting with typical clinical presentations of Alzheimer's disease versus atypical clinical presentations of Alzheimer's disease versus non-Alzheimer's neurodegenerative disorders.
Time frame: 12 months
To assess changes in participant management by clinical disease stage.
Describe the association of Alzheimer's disease CSF biomarker testing results with changes in management in individuals presenting with mild cognitive symptoms versus dementia.
Time frame: 12 months
To assess the impact of Alzheimer's disease core CSF biomarker testing on the change in diagnosis and diagnostic confidence.
Determine the percentage change in diagnosis and physician-rated diagnostic confidence from the pre-biomarker time-point to the post-biomarker time-point.
Time frame: 12 months
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