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

NCT07422038 | Not Yet Recruiting

• 1 other identifier: BioMIND 2
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

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

  throughout study until completion, approximately 2 years

• evaluate the impact of biomarker results on participants

  survey given before results and within 1 month after results are received

• understand the regional impact of biomarker testing

  at time of referral

Other Outcomes (2)

• determine the correlation between the plasma biomarker results 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

• determine the correlation between clinical presentation and the sensitivity and specificity of the plasma biomarker results

  through study completion, approximately 2 years.

Study Arms (3)

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

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma will be retained for future research related to biomarkers in Alzheimer's Disease

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Kayla Vander Ploeg, RN, BScN

CONTACT

519-685-4292; kayla.vanderploeg@sjhc.london.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Geriatrician

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share