Alzheimer Disease (AD)BioMIND 2NCT07422038
BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) - Improving Access to Alzheimer's Disease Diagnostics: A Pragmatic System Level Intervention
An observational study of Alzheimer Disease (AD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease (AD)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Alzheimer Disease (AD)
- Keywords
- mild cognitive impairment, dementia, biomarkers
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Referral to Diagnosis with biomarkers
Will be measured by number of days between referral and disclosure of results
Measured: Group A - under 250 days. Group B and C - under 365 days
Secondary outcomes (3)
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
Measured: throughout study until completion, approximately 2 years
evaluate the impact of biomarker results on participants
determined by pre and post biomarker results surveys and focus group feedback
Measured: 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
Measured: at time of referral
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaspreet Bhangu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422038
- Sponsor's protocol ID
- BioMIND 2
- Acronym
- BioMIND 2
- Status last verified
- Feb 2026
- First submitted
- 31 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) - Improving Access to Alzheimer's Disease Diagnostics: A Pragmatic System Level Intervention
- ClinicalTrials.gov ID
- NCT07422038
- Acronym / sponsor ID
- BioMIND 2 / BioMIND 2
- Conditions
- Alzheimer Disease (AD)
- Keywords
- mild cognitive impairment, dementia, biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
evaluate the impact of biomarker results on participants
Time frame: survey given before results and within 1 month after results are received
understand the regional impact of biomarker testing
Time frame: at time of referral
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease (AD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayla Vander Ploeg, RN, BScN (519-685-4292 ext. 42255, kayla.vanderploeg@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from Referral to Diagnosis with biomarkers (time frame: Group A - under 250 days. Group B and C - under 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.