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

NCT05002699 | Unknown

• 1 other identifier: H17-01339
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Alzheimer Disease; Dementia; Cognitive Impairment; Mild Cognitive Impairment

Keywords

Biomarkers; Cerebrospinal fluid; Amyloid beta-Peptides; tau Proteins

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 Outcomes (3)

• To assess changes in participant management among various clinical presentations.

  12 months

• To assess changes in participant management by clinical disease stage.

  12 months

• To assess the impact of Alzheimer's disease core CSF biomarker testing on the change in diagnosis and diagnostic confidence.

  12 months

Interventions

Alzheimer's disease CSF biomarkers DIAGNOSTIC_TEST

Measurement of amyloid beta peptide 1-42, amyloid beta peptide 1-40, and total tau in cerebrospinal fluid.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Brain Canada: collaborator
• Health Canada: collaborator
• Michael Smith Foundation for Health Research: collaborator
• Women's Brain Health Initiative: collaborator
• St. Paul's Foundation: collaborator

Study Sites (4)

Northern Health

Prince George, British Columbia, Canada

Location

Providence Health Care

Vancouver, British Columbia, Canada

Location

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Location

Island Health

Victoria, British Columbia, Canada

Location

Related Publications (6)

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514249 BACKGROUND

• DeMarco ML, Nguyen Q, Fok A, Hsiung GR, van der Gugten JG. An automated clinical mass spectrometric method for identification and quantification of variant and wild-type amyloid-beta 1-40 and 1-42 peptides in CSF. Alzheimers Dement (Amst). 2020 Jun 30;12(1):e12036. doi: 10.1002/dad2.12036. eCollection 2020.

  PMID: 32617385 BACKGROUND

• American Psychiatric Association. Diagnostic and statistical manual of mental disorders: DSM-IV [Internet]. 4th ed. Washington (DC): American Psychiatric Association; 1994 [cited 2010 Mar 8]. 866 p.

  BACKGROUND

• Johnson KA, Minoshima S, Bohnen NI, Donohoe KJ, Foster NL, Herscovitch P, Karlawish JH, Rowe CC, Hedrick S, Pappas V, Carrillo MC, Hartley DM. Update on appropriate use criteria for amyloid PET imaging: dementia experts, mild cognitive impairment, and education. J Nucl Med. 2013 Jul;54(7):1011-3. doi: 10.2967/jnumed.113.127068. Epub 2013 Jun 10.

  PMID: 23753186 BACKGROUND

• McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.

  PMID: 21514250 BACKGROUND

• Shaw LM, Arias J, Blennow K, Galasko D, Molinuevo JL, Salloway S, Schindler S, Carrillo MC, Hendrix JA, Ross A, Illes J, Ramus C, Fifer S. Appropriate use criteria for lumbar puncture and cerebrospinal fluid testing in the diagnosis of Alzheimer's disease. Alzheimers Dement. 2018 Nov;14(11):1505-1521. doi: 10.1016/j.jalz.2018.07.220. Epub 2018 Oct 10.

  PMID: 30316776 BACKGROUND

Related Links

• IMPACT-AD BC study website

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Mari L. DeMarco, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: February 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: March 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

CA (4)