Biomarkers in a Candian Memory Clinic (BioMIND)

Biomarkers as Part of Diagnostic Workup for Alzheimer's Disease: A Feasibility Study in a Canadian Memory Clinic

This is a prospective, observational, case control study in a real-world cohort of patients referred by a primary care physician to a tertiary memory clinic for cognitive concerns. This study's main objective is to determine the effect of using standardized criteria (based on eligibility for disease modifying treatment (DMT)) to triage patients towards biological staging of disease with biomarker testing.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alzheimer's Disease (AD)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C0A7
      • Parkwood Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 100 participants will be included from referrals to the Aging Brain and Memory Clinic or Cognitive Neurology. Study investigators will use the CSF and PET scan results to complete the respective surveys. This is a convenience sample so there is not a statistical difference in the number of samples selected as part of this study.

Description

Inclusion Criteria:

1. Individual with MCI (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
2. MoCA score must be 18 to 28 inclusive
3. Age 55 to 80 years inclusive
4. Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
5. Group A - must have a clinical memory assessment appointment scheduled at Parkwood Institute within 18 months of baseline
6. Group B - must have had a clinical memory assessment appointment at Parkwood Institute within 18 months of baseline

Exclusion Criteria:

• 1) 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).

  2) 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.

  3) 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 4) History of epilepsy, fits, or unexplained blackouts other than vasovagal syncope within 10 years before screening.

  5) Malignant neoplasms within 3 years (except for basal cell or squamous cell carcinoma in situ of the skin) 6) Women of child bearing potential and breastfeeding mothers 7) Individuals who require sedation to complete PET scan. 8) Individuals who are unable to complete assessments in the English language. 9) Individuals who cannot provide consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; Participants who have not yet completed assessment at Parkwood Institute for memory concerns
Group B; Participants who have completed assessment at Parkwood Institute for memory concerns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD.	Analysis of resources needed to conduct testing including personnel required, time requirements, space, and resources/equipment	through study completion, approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm.	Measured by investigator pre and post biomarker questionnaire indicating clinical suspicion, confidence of clinical suspicion, tests to be ordered, and management plan.	through study completion, approximately one year
Evaluate the impact of biomarker results on participants	Determined by Participant Pre and Post Biomarker Questionnaire	through study completion, approximately one year

Other Outcome Measures

Outcome Measure	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	through study completion, approximately one year

Collaborators and Investigators

• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
• Collaborators: Parkwood Hospital, London, Ontario

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: dementia; biomarkers; mild cognitive impairment
• Other Study ID Numbers: BioMIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No