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Enrolling by Invitation

NCT Number: NCT06843109

Biomarkers in a Candian 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.

Enrolling by Invitation

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkwood Institute

London, Ontario, N6C0A7, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Individual with MCI (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
  • MoCA score must be 18 to 28 inclusive
  • Age 55 to 80 years inclusive
  • 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.
  • Group A - must have a clinical memory assessment appointment scheduled at Parkwood Institute within 18 months of baseline
  • 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).
  • 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 4) History of epilepsy, fits, or unexplained blackouts other than vasovagal syncope within 10 years before screening.
  • 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

Treatment and study plan

Primary outcomes

  1. Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD.

    Time frame: through study completion, approximately 1 year

    Analysis of resources needed to conduct testing including personnel required, time requirements, space, and resources/equipment

Secondary outcomes

  1. Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm.

    Time frame: through study completion, approximately one year

    Measured by investigator pre and post biomarker questionnaire indicating clinical suspicion, confidence of clinical suspicion, tests to be ordered, and management plan.

  2. Evaluate the impact of biomarker results on participants

    Time frame: through study completion, approximately one year

    Determined by Participant Pre and Post Biomarker Questionnaire

Other outcomes

  1. Determine the correlation between the plasma biomarker results and CSF results and amyloid PET results

    Time frame: through study completion, approximately one year

    Measured by the percent agreement between plasma biomarker and CSF results and amyloid PET results

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Parkwood Hospital, London, Ontario

Registry information

Official study title

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

Acronym: BioMIND

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

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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