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NCT Number: NCT07422038

BioMIND (Biomarkers for the Molecular Identification of Neurodegenerative Dementia) - Improving Access to Alzheimer's Disease Diagnostics: A Pragmatic System Level Intervention

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Other outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Vander Ploeg, RN, BScN

CONTACT

[email protected]

519-685-4292 ext. 42255

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Acronym: BioMIND 2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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