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Enrolling by invitationNCT06843109BioMINDUpdated Feb 24, 2025

Biomarkers in a Candian Memory Clinic

An observational study in Alzheimer's Disease (AD), sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Enrolling by invitation at 1 site in Canada. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
55 Years to 80 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Alzheimer's Disease (AD)

Keywords

  • mild cognitive impairment
  • dementia
  • biomarkers
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In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's planned enrollment of 100 is below the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 327 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, approximately 1 year

Secondary outcomes

  1. 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.

    Time frame: through study completion, approximately one year

  2. Evaluate the impact of biomarker results on participants

    Determined by Participant Pre and Post Biomarker Questionnaire

    Time frame: through study completion, approximately one year

Other outcomes

  1. 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

    Time frame: through study completion, approximately one year

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Study locations

1 site
  • Parkwood Institute
    London, Ontario N6C0A7, Canada
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References and documents

Individual participant data

Plan to share: No — Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06843109
Collaborators
Parkwood Hospital, London, Ontario
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Jun 11, 2024
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Feb 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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