BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) - Improving Access to Alzheimer's Disease Diagnostics: A Pragmatic System Level Intervention (BioMIND 2)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kayla Vander Ploeg, RN, BScN
- Phone Number: 42255 519-685-4292
- Email: kayla.vanderploeg@sjhc.london.on.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Individual with MCI or early dementia (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
- MoCA score must be 10 to 28 inclusive
- Age 50 to 90 years inclusive
Exclusion Criteria:
- Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc).
- Presence of any neurological, psychiatric, or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including, but not limited to, pre-manifest Huntington's disease, multiple sclerosis, Parkinson's disease, Down's syndrome, active alcohol/drug abuse or major psychiatric disorders including, but not limited to, schizophrenia, schizoaffective disorder, or bipolar affective disorder or current episode of major depressive disorder.
- Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures
- Pregnant women and breastfeeding mothers.
- Individuals who are unable to complete assessments in the English language.
- Individuals who cannot provide consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Group A
Biomarker First - Participants who have not yet completed assessment at Parkwood Institute in the Aging Brain and Memory Clinic for memory concerns
|
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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
|
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time from Referral to Diagnosis with biomarkers
Time Frame: Group A - under 250 days. Group B and C - under 365 days
|
Will be measured by number of days between referral and disclosure of results
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Group A - under 250 days. Group B and C - under 365 days
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: throughout study until completion, approximately 2 years
|
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
|
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evaluate the impact of biomarker results on participants
Time Frame: survey given before results and within 1 month after results are received
|
determined by pre and post biomarker results surveys and focus group feedback
|
survey given before results and within 1 month after results are received
|
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understand the regional impact of biomarker testing
Time Frame: at time of referral
|
measured by number of participants enrolled in Group C compared to the number of patients referred for testing
|
at time of referral
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determine the correlation between the plasma biomarker results and CSF results and amyloid PET results
Time Frame: this will be analyzed at study completion, approximately 2 years. results will be correlated at time of study procedure
|
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
|
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determine the correlation between clinical presentation and the sensitivity and specificity of the plasma biomarker results
Time Frame: through study completion, approximately 2 years.
|
measured by MoCA, ADL score, ACDS-ADL-MCI
|
through study completion, approximately 2 years.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BioMIND 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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