Alzheimer DiseaseIMPACT-AD BCNCT05002699
Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia
An observational study of Alzheimer Disease and Dementia, run by University of British Columbia at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Cognitive Impairment
- What is being tested?
- Alzheimer's disease CSF biomarkers
- How many people
- 120 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Feb 2019to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Northern Health
Prince George, British Columbia
Providence Health Care
Vancouver, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia
Island Health
Victoria, British Columbia
About this study
Official title: 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.
Read the 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.
- Being tested
- Alzheimer's disease CSF biomarkers
- Keywords
- Biomarkers, Cerebrospinal fluid, Amyloid beta-Peptides, tau Proteins
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alzheimer's disease CSF biomarkersDiagnostic test
Measurement of amyloid beta peptide 1-42, amyloid beta peptide 1-40, and total tau in cerebrospinal fluid.
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Alzheimer's disease drug therapy;
- Other relevant drug therapy;
- Diagnostic procedure, imaging, other biofluid testing;
- Referral or counselling.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
To assess changes in participant management among various clinical presentations.
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.
Measured: 12 months
To assess changes in participant management by clinical disease stage.
Describe the association of Alzheimer's disease CSF biomarker testing results with changes in management in individuals presenting with mild cognitive symptoms versus dementia.
Measured: 12 months
To assess the impact of Alzheimer's disease core CSF biomarker testing on the change in diagnosis and diagnostic confidence.
Determine the percentage change in diagnosis and physician-rated diagnostic confidence from the pre-biomarker time-point to the post-biomarker time-point.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Feb 2019
- Primary completionAug 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Brain Canada, Health Canada, Michael Smith Foundation for Health Research, Women's Brain Health Initiative, St. Paul's Foundation
- Responsible party
- Principal investigator, Mari L. DeMarco, PhD, University of British Columbia
- Investigators
- Mari L. DeMarco, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002699
- Sponsor's protocol ID
- H17-01339
- Acronym
- IMPACT-AD BC
- Status last verified
- May 2022
- First submitted
- 4 Aug 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21514249DeMarco 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.
PubMed 32617385American 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.
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.
PubMed 23753186McKhann 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.
PubMed 21514250Shaw 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.
PubMed 30316776
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Alzheimer's Disease Diagnostics in British Columbia (IMPACT-AD BC)
- ClinicalTrials.gov ID
- NCT05002699
- Acronym / sponsor ID
- IMPACT-AD BC / H17-01339
- Keywords
- Biomarkers, Cerebrospinal fluid, Amyloid beta-Peptides, tau Proteins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Brain Canada, Health Canada, Michael Smith Foundation for Health Research, Women's Brain Health Initiative, St. Paul's Foundation
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alzheimer's disease CSF biomarkersMeasurement of amyloid beta peptide 1-42, amyloid beta peptide 1-40, and total tau in cerebrospinal fluid. | Diagnostic test | – |
Primary outcome
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.
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.
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.
3 secondary outcomes
To assess changes in participant management among various clinical presentations.
Time frame: 12 months
To assess changes in participant management by clinical disease stage.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 21514249Albert 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.
- Background: PubMed 32617385DeMarco 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.
- BackgroundAmerican 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: PubMed 23753186Johnson 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.
- Background: PubMed 21514250McKhann 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.
- Background: PubMed 30316776Shaw 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.
- IMPACT-AD BC study websiteLink provided by the sponsor.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mari L. DeMarco, PhD principal investigator
University of British Columbia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by University of British Columbia at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002699, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.