Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia

Last updated: May 16, 2022
Sponsor: University of British Columbia
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Learning Disorders

Alzheimer's Disease

Dementia

Treatment

N/A

Clinical Study ID

NCT05002699
H17-01339
  • Ages > 40
  • All Genders

Study Summary

The 'Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia' (IMPACT-AD BC) study is an observational, longitudinal cohort study that will examine the impact of cerebrospinal fluid (CSF) testing for core Alzheimer's disease biomarkers on clinical decision making, diagnosis and health system utilization. In addition to data collection from physicians, the study will engage patients and their care partners in assessing the value of biomarker testing. IMPACT-AD BC investigators hypothesize that testing for CSF biomarkers of Alzheimer's disease in individuals with cognitive impairment, as part of routine clinical care, improves clinical management, diagnostic certainty, diagnostic accuracy, and healthcare resource utilization, and that patients and their care partners find the information valuable in planning for the future.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is either a dementia specialist, or a patient of a consenting dementiaspecialist;
  • Patient participant is age 40 and older;
  • Patient participant has a diagnosis verified by a dementia specialist within 24 monthsof: subjective cognitive decline (Shaw et al., 2018), or mild cognitive impairment ordementia, according to DSM-IV (DSM-IV-TR, 2000) and/or National Institutes ofAging-Alzheimer's Association (Albert et al., 2011; McKhann et al., 2011) criteria;
  • The etiologic cause of cognitive impairment is uncertain after a comprehensiveevaluation by a dementia specialist, including general medical and neurologicalexamination, mental status testing including standard measures of cognitiveimpairment, laboratory testing, and structural neuroimaging;
  • Cognitive disorder is considered to be on the Alzheimer's continuum, including, butnot limited to, mild cognitive impairment with suspected Alzheimer's pathology thatdoes not reach the criteria for dementia;
  • Dementia specialist deems that CSF Alzheimer's disease biomarkers are appropriate asper routine clinical care;
  • Patient participant consents to a lumbar puncture for CSF analysis as part of clinicalcare.

Exclusion

Exclusion Criteria:

  • Patient participant has normal cognition;
  • Patient participant lumbar puncture requires imaging guidance;
  • Knowledge of amyloid status, in the opinion of the treating dementia specialist, maycause significant psychological harm or otherwise negatively impact the patient orfamily;
  • Amyloid status already known to patient or dementia specialist based on prior Aβpositron emission tomography (PET) imaging or previous CSF analysis;
  • Aβ and tau CSF biomarkers ordered solely based on a family history of dementia,presence of apolipoprotein E4 genotype, or as a screening test for asymptomaticindividuals;
  • Aβ and tau CSF biomarkers ordered for non-medical purposes (e.g., legal, employmentscreening, insurance coverage, patient or family member curiosity);
  • Current (i.e., active) patient participation in an anti-amyloid or anti-tautherapeutic trial;
  • Presence of other significant chronic brain disease in patient (e.g., malignanttumor);
  • Patient had symptomatic stroke or transient ischemic attack within the previous 12months;
  • Life expectancy of patient is less than 24 months based on medical co-morbidities;
  • Lack of caregiver who can provide corroborative information if the patient participantlacks capacity to do so themselves.

Study Design

Total Participants: 120
Study Start date:
February 01, 2019
Estimated Completion Date:
March 31, 2023

Study Description

The IMPACT-AD BC study is an observational, longitudinal cohort study designed to understand the impact of cerebrospinal fluid (CSF) testing for core Alzheimer's disease biomarkers on clinical decision making, diagnosis, health system utilization, and patients and their care partners.

Dementia specialists from multiple sites in the Canadian province of British Columbia will be approached to provide informed consent to participate. When these physicians order Alzheimer's disease CSF biomarker testing as part of routine care (DeMarco et al 2020), their patients will be eligible to participate in the study. Eligible patients (the patient participants) and their study partners (e.g., a family member or care partner) will be approached to provide informed consent to participate. The dementia specialists will provide diagnosis and management plans for their consenting patient participants before and after Alzheimer's disease CSF biomarker results. One year after release of the Alzheimer's disease CSF biomarker results, dementia specialists complete another questionnaire to assess the stability of their responses. In addition to these data, the study will collect patient participant/care partner perspectives on CSF biomarker testing post-results disclosure.

Via the IMPACT-AD BC study, the investigators will collect the first data of its kind on the utility of CSF biomarkers in routine care in Canada, with the overall goal of improving care and support systems for individuals living with neurodegenerative disorders.

Connect with a study center

  • Northern Health

    Prince George, British Columbia
    Canada

    Site Not Available

  • Providence Health Care

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Vancouver Coastal Health

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Island Health

    Victoria, British Columbia
    Canada

    Site Not Available

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