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The BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) pilot study was launched at Parkwood Hospital in response to national calls for implementation of biomarker diagnostics in Canada. It evaluated the feasibility, impact, and equity of introducing blood biomarker testing, lumbar punctures, and amyloid Positron Emission Tomography (PET) scans into clinical pathways. The study found that the Biomarker-First pathway significantly reduced the time from referral to diagnosis (195 versus 533 days - a difference of 318 days), demonstrating the value in implementing clinical biomarkers to bypass bottlenecks created by the need for specialist assessments. Building on these findings, the next phase of BioMIND is aimed at reducing wait times for biomarker diagnostics for patients with symptoms suggestive of mild cognitive impairment (MCI) and early AD.
The aim is to understand these wait times to biomarker testing using a nurse-led triage support tool. Group A participants will be pre-screened using this tool that includes the eligibility criteria for the study. This will help understand, out of everybody coming to the Aging Brain and Memory Clinic (ABMC) who've indicated interest in research, which people would be eligible to receive AD biomarkers if they were clinically available. Comparison of Group A's time to diagnosis with Group B and C's, who would have had a specialist appointment within 18 months and were referred to research to receive AD biomarkers through this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Biomarker First - Participants who have not yet completed assessment at Parkwood Institute in the Aging Brain and Memory Clinic for memory concerns | ||
| Group B | Biomarker Second from Aging Brain and Memory Clinic - Participants who have completed assessment at Parkwood Institute in the Aging Brain and Memory Clinic for memory concerns and have been referred after their specialist visit to the study | ||
| Group C | Biomarker Second from Regional Partners - Participants who have completed assessment for memory concerns from a clinician outside of the Aging Brain and Memory Concern and have referred directly to the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Time from Referral to Diagnosis with biomarkers | Will be measured by number of days between referral and disclosure of results | Group A - under 250 days. Group B and C - under 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Develop a targeted decision support tool for the early identification of patients with MCI or early AD in Group A with diagnostic accuracy of 80% or higher | measured by the number of participants in Group A that are biomarker positive for AD compared to the participants who are biomarker negative for AD | throughout study until completion, approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| determine the correlation between the plasma biomarker results and CSF results and amyloid PET results | measured by the percent agreement between plasma biomarker and CSF results and amyloid PET results | this will be analyzed at study completion, approximately 2 years. results will be correlated at time of study procedure |
Inclusion Criteria:
Exclusion Criteria:
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up to 200 participants will be included from referrals to the Aging Brain and Memory Clinic or Cognitive Clinical Research Group. Study investigators will use the CSF and amyloid PET results to complete the respective surveys.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla Vander Ploeg, RN, BScN | Contact | 519-685-4292 | 42255 | kayla.vanderploeg@sjhc.london.on.ca |
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Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared
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serum and plasma will be retained for future research related to biomarkers in Alzheimer's Disease
| evaluate the impact of biomarker results on participants | determined by pre and post biomarker results surveys and focus group feedback | survey given before results and within 1 month after results are received |
| understand the regional impact of biomarker testing | measured by number of participants enrolled in Group C compared to the number of patients referred for testing | at time of referral |
| determine the correlation between clinical presentation and the sensitivity and specificity of the plasma biomarker results |
measured by MoCA, ADL score, ACDS-ADL-MCI |
| through study completion, approximately 2 years. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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