Clinical trial NCT06843109: Biomarkers in a Candian Memory Clinic
Official title: Biomarkers as Part of Diagnostic Workup for Alzheimer's Disease: A Feasibility Study in a Canadian Memory Clinic
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alzheimer&#39;s Disease (AD)
Keywords: mild cognitive impairment
dementia
biomarkers
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Parkwood Hospital, London, Ontario
First posted: 2025-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD.
timeFrame: through study completion, approximately 1 year
Secondary outcomes:
measure: Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm.
timeFrame: through study completion, approximately one year
measure: Evaluate the impact of biomarker results on participants
timeFrame: through study completion, approximately one year
Other outcomes:
measure: Determine the correlation between the plasma biomarker results and CSF results and amyloid PET results
timeFrame: through study completion, approximately one year
Locations:
city: London
country: Canada
facility: Parkwood Institute
state: Ontario
Study officials:
References: