Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia (IMPACT-AD BC)

May 16, 2022 updated by: Mari L. DeMarco, PhD, University of British Columbia

Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia (IMPACT-AD BC)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Prince George, British Columbia, Canada
        • Northern Health
      • Vancouver, British Columbia, Canada
        • Providence Health Care
      • Vancouver, British Columbia, Canada
        • Vancouver Coastal Health
      • Victoria, British Columbia, Canada
        • Island Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient participants presenting with suspected preclinical, prodromal and Alzheimer's dementia, and meeting the appropriate use criteria for lumbar puncture and CSF biomarker testing (Shaw et al., 2018), will be enrolled along with their study partner and referring dementia specialist. A dementia specialist is defined as a self-identified physician trained and board-certified in neurology, psychiatry, or geriatric medicine who devotes a substantial proportion (≥ 25%) of patient contact time to the evaluation and care of adults with acquired cognitive impairment or dementia (Johnson et al., 2013).

Description

Inclusion Criteria:

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

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, may cause significant psychological harm or otherwise negatively impact the patient or family;
  • Amyloid status already known to patient or dementia specialist based on prior Aβ positron 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 asymptomatic individuals;
  • Aβ and tau CSF biomarkers ordered for non-medical purposes (e.g., legal, employment screening, insurance coverage, patient or family member curiosity);
  • Current (i.e., active) patient participation in an anti-amyloid or anti-tau therapeutic trial;
  • Presence of other significant chronic brain disease in patient (e.g., malignant tumor);
  • Patient had symptomatic stroke or transient ischemic attack within the previous 12 months;
  • 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 participant lacks capacity to do so themselves.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the impact of Alzheimer's disease core CSF biomarker testing on the management of patients meeting the appropriate use criteria for lumbar puncture and testing.
Time Frame: 12 months

Determine the percent change between intended management (without biomarkers) and actual patient management (with biomarkers) in a composite measure of at least one of the following:

  1. Alzheimer's disease drug therapy;
  2. Other relevant drug therapy;
  3. Diagnostic procedure, imaging, other biofluid testing;
  4. Referral or counselling.
12 months
To describe the participant's experience with Alzheimer's disease CSF biomarker testing.
Time Frame: 6 months
Describe the participant's experience with Alzheimer's disease CSF biomarker testing and evaluate the impact of testing on their planning and decision-making via interviews one-month and six-months post-disclosure of CSF biomarker results.
6 months
To describe the study partner's experience with Alzheimer's disease CSF biomarker testing.
Time Frame: 6 months
Describe the study partner's experience with Alzheimer's disease CSF biomarker testing and evaluate the impact of testing on their planning and decision-making via interviews one-month and six-months post-disclosure of CSF biomarker results.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess changes in participant management among various clinical presentations.
Time Frame: 12 months
Describe the association of Alzheimer's disease CSF biomarker testing results with changes in management in individuals, from prodromal to dementia stage, presenting with typical clinical presentations of Alzheimer's disease versus atypical clinical presentations of Alzheimer's disease versus non-Alzheimer's neurodegenerative disorders.
12 months
To assess changes in participant management by clinical disease stage.
Time Frame: 12 months
Describe the association of Alzheimer's disease CSF biomarker testing results with changes in management in individuals presenting with mild cognitive symptoms versus dementia.
12 months
To assess the impact of Alzheimer's disease core CSF biomarker testing on the change in diagnosis and diagnostic confidence.
Time Frame: 12 months
Determine the percentage change in diagnosis and physician-rated diagnostic confidence from the pre-biomarker time-point to the post-biomarker time-point.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Health Canada
Brain Canada
Michael Smith Foundation for Health Research
Women's Brain Health Initiative
St. Paul's Foundation

Investigators

  • Principal Investigator: Mari L. DeMarco, PhD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

August 4, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-01339

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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