Mild Cognitive ImpairmentNCT07041450
Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by MoCA Clinic and Institute at 1 site in Canada.
Trial summary
This study evaluates a diagnostic screening solution for Alzheimer's disease (AD) using digital cognitive assessments and blood-based biomarkers. The aim is to reduce time-to-treatment for patients who may benefit from disease-modifying therapy (DMT). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Dementia
- What is being tested?
- Digital MoCA, XpressO and MoCA
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2025to 14 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include 500 patients that have been referred to the MoCA Clinic from the Greater Montreal Area. There will be a mix of English and French speaking with approximately 80% having French as a first language.
Who may be able to join
- Must be referred to the MoCA Clinic; including both new patients and existing patients who have been seen >1 year ago
- Present with cognitive impairment or cognitive complaints.
- Must have the ability to understand the purpose and risk of the Study and provide informed consent.
- Must have an identified study partner (informant/care partner), who has frequent and sufficient contact with the participant to be able to provide accurate information about the participant's cognitive and functional abilities. The study partner must be available by phone to provide information to the study staff about the participant and agrees to attend one in-person visit at the MoCA Clinic which requires partner input. The study partner should be available for the duration of the study.
Who cannot join
- An established diagnosis (other than AD), that is a cause for a candidate's cognitive impairment (e.g. substance abuse, cerebrovascular conditions, Lewy body dementia, fronto-temporal dementia, recent head trauma).
- Blood donation (1 unit) within 1 month prior to Study screening.
- Inability to comply with requirements to complete essential components of the Study (e.g. visual impairment, severe kidney disease or ongoing kidney treatment)
- Patients already enrolled in any clinical trial for AD at time of Study screening
- Other unspecified reasons that, in the opinion of the Principal Investigator, or MoCA Clinic and Institute, make the candidate unsuitable for enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
MoCA Clinic and Institute
Greenfield Park, Quebec, J4V 2J2
Joana Krieger, 450 672-7766 ext. 293, joana.krieger@mocacognition.com
Amy Dam, amy.dam@mocacognition.com
About this study
Official title: A Cohort Study on Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
This study evaluates a diagnostic screening solution for Alzheimer's disease (AD) using digital cognitive assessments and blood-based biomarkers. The aim is to reduce time-to-treatment for patients who may benefit from disease-modifying therapy (DMT). The study involves 500 patients referred to the MoCA Clinic in Montreal. Clinical stages will be assessed using digital tools from MoCA Test Inc. (MoCA Cognition), and biological stages via blood biomarkers. Data collected includes demographics, cognitive scores, health questionnaires, biomarker levels, and neurologist-determined eligibility for DMT. The study will result in an algorithm to support diagnostic triage and estimate the efficiency and equity of a fast-track diagnostic pathway. Exploratory endpoints include validation of self-administered digital tools, health-economic estimates, and predictors of cognitive decline.
Read the detailed description
This study will evaluate a diagnostic screening solution based on clinical and biological stages of Alzheimer's disease (AD) ("Study"). The clinical stages will be screened using the digital tools from MoCA Test Inc. ("MoCA Cognition"). The biological stages will be screened using blood-based biomarkers ("BBM"). Based on the results of this Study, we will establish efficient and equitable criteria for diagnostic triage. The Study will result in an algorithm that can assist in assigning patients into a fast-track diagnostic pathway to determine if they are eligible or not for AD treatment with a disease modifying therapy ("DMT").
Primary objective: To develop and evaluate a diagnostic screening solution based on blood-based biomarkers and digital measures of cognition that could reduce the time-to-treatment for patients who are candidates for AD treatment with a disease modifying therapy.
Primary endpoint: Detailed cohort description of patients referred to the memory clinic MoCA Clinic Inc. ("MoCA Clinic"). This includes: (1) demographic characteristics; (2) cognitive screening scores measured by a digital MoCA via the MoCA score and XpressO application; (3) biomarker levels including PrecivityAD2 and MTBR; (4) the proportion of DMT candidates determined by a neurologist, (5) the causes and frequencies of why patients are not eligible for AD treatment (6) the number of diagnostic follow-up tests required after screening (MRI, PET/CSF), (7) the baseline referral times for future comparison against the fast-track pathway and (8) the time-until-diagnosis.
Secondary endpoints: Based on the primary endpoints, we will estimate the potential benefits of a diagnostic screening solution. This includes an estimation of the number of patients that would potentially miss out on the treatment window in the current diagnostic workflow.
Exploratory endpoints: (1) Validation of a self-administered digital version of the MoCA test ("MoCA Solo") compared to the paper MoCA test, (2) Evaluation of MoCA Solo as digital biomarker within the screening algorithm, (3) Health-economic estimation of the number and costs of follow-up tests at different levels of specificity, (4) The role of age, sex and education on the performance of the screening solution, (5) Prediction of time until patient would progress to moderate dementia based on baseline MoCA score and age, (6) Description of participant's history of symptoms and healthcare usage, (7) Correlation between the patient-centered version and the clinician versions of the Amyloid Treatment Screening Tool (ATST), (8) Evaluate the correlation between the MoCA Brain Health Questionnaire (MBHQ) score and participant diagnosis, (9) Evaluate the effect of the addition of MTBR results into screening algorithm.
Participants: Study population will include 500 patients who have been referred to the MoCA Clinic, including both new patients and existing patients. Based on prior referrals, we anticipate 60% female, 55-90 years, 80% French / 20% English, approximately 20% subjective cognitive decline (SCD), 60% mild cognitive impairment (MCI) and 20% mild dementia.
Study Location: The study is conducted as a single-center study with patients from the Montreal area. Patients will be enrolled at the MoCA Clinic where full informed consent will be obtained.
Study Visits: In the active study period, two MoCA Clinic visits will be planned within 1-3 months: Visit 1 includes data collection feasible at a primary care physician: digital cognitive assessments, blood sample collection and amyloid-treatment screening test. Visit 2 includes cognitive assessment, data collection and diagnosis typical for a neurological visit. After the blood sample is analyzed, the prediction of diagnosis and eligibility for DMT will be made using our algorithm. After the active study period, at 6 months, information from the medical records will be reviewed to evaluate clinical follow-up.
This study is supported by an independent research grant from Eli Lilly Canada Inc.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia
- Being tested
- Digital MoCA, XpressO, MoCA, Blood-based Biomarkers (BBM), Amyloid Treatment Screening Tool (ATST)
- Keywords
- blood-based biomarkers, digital cognitive assessment, diagnostic screening, MoCA, disease-modifying therapy, older adults, early detection, Montreal Cognitive Assessment
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital MoCADiagnostic test
Also called MoCA Solo
A digital version of the Montreal Cognitive Assessment used to evaluate cognitive function. Administered on a tablet at Visit 1 or Visit 2 (randomized).
XpressODiagnostic test
A digital cognitive pre-screening tool used to screen for cognitive function. Administered on a tablet at Visit 1.
MoCADiagnostic test
The standard paper-baed Montreal Cognitive Assessment used to evaluate cognitive function. Administered at Visit 1 or Visit 2 (randomized), opposite the digital MoCA.
Blood-based Biomarkers (BBM)Diagnostic test
Participants provide a blood sample that is analyzed for Alzheimer's disease-related biomarkers, including PrecivityAD2 and MTBR. These biomarkers are used to assess the biological stage of disease and support diagnostic triage and eligibility assessment for disease-modifying therapy (DMT)
Amyloid Treatment Screening Tool (ATST)Other
A questionnaire administered to assess eligibility for amyloid-targeted therapies. Both clinician and patient-centered versions are used.
MoCA Brain Health Questionnaire (MBHQ)Other
A questionnaire designed to capture participants' physical health, emotional well-being, diet, exercise, and social engagement as it relates to cognitive health. Responses are used as part of exploratory analyses to evaluate associations with cognitive status and Alzheimer's disease diagnosis.
MoCA Medical QuestionnaireOther
A structured questionnaire administered to participants to gather information on their medical history, including prior diagnoses, medications, and other health conditions. This data helps to contextualize cognitive symptoms and support diagnostic decision-making in the study.
Functional Activities Questionnaire+ (FAQ+)Other
A questionnaire designed to assess the participant's ability to perform daily activities, providing insights into their functional status and cognitive impairment. It is a longer version of the original FAQ questionnaire. It is used as part of the screening and exploratory analysis to better understand the relationship between functional abilities and Alzheimer's disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Observational Cohort | The study population will include 500 patients that have been referred to the MoCA Clinic from the Greater Montreal Area. This includes individuals with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and mild dementia.
Participants complete cognitive tests, health and cognition questionnaires, and undergo a blood test for blood biomarker testing. Receives: Diagnostic Test: Digital MoCA; Diagnostic Test: XpressO; Diagnostic Test: MoCA; Diagnostic Test: Blood-based Biomarkers (BBM); Other: Amyloid Treatment Screening Tool (ATST); Other: MoCA Brain Health Questionnaire (MBHQ); Other: MoCA Medical Questionnaire; Other: Functional Activities Questionnaire+ (FAQ+) | |
| Paper MoCA Subgroup | Participants will be randomly assigned to complete either the paper MoCA or the digital MoCA Solo at Visit 1, with the other version completed at Visit 2. The Paper MoCA Subgroup will complete the paper MoCA at Visit 1. Receives: Diagnostic Test: Digital MoCA; Diagnostic Test: XpressO; Diagnostic Test: MoCA; Diagnostic Test: Blood-based Biomarkers (BBM); Other: Amyloid Treatment Screening Tool (ATST); Other: MoCA Brain Health Questionnaire (MBHQ); Other: MoCA Medical Questionnaire; Other: Functional Activities Questionnaire+ (FAQ+) | |
| MoCA Solo Subgroup | Participants will be randomly assigned to complete either the paper MoCA or the digital MoCA Solo at Visit 1, with the other version completed at Visit 2. The MoCA Solo Subgroup will complete the MoCA Solo at Visit 1. Receives: Diagnostic Test: Digital MoCA; Diagnostic Test: XpressO; Diagnostic Test: MoCA; Diagnostic Test: Blood-based Biomarkers (BBM); Other: Amyloid Treatment Screening Tool (ATST); Other: MoCA Brain Health Questionnaire (MBHQ); Other: MoCA Medical Questionnaire; Other: Functional Activities Questionnaire+ (FAQ+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
The primary outcome metric is the time to diagnosis for patients that are eligible vs. not eligible for anti-amyloid medication. In this case, time to diagnosis is defined by the time it takes to determine if patient is eligible anti-amyloid medication or not.
Measured: From enrollment to 6-month follow-up
Secondary outcomes (1)
Benefit of Diagnostic Screening
This outcome measures the estimated benefit of implementing a diagnostic screening solution by comparing the number of patients who would miss the treatment window for Alzheimer's disease under the current diagnostic workflow versus a hypothetical fast-track workflow incorporating blood-based biomarkers and digital cognitive assessments. The estimate will be based on observed time-to-diagnosis, biomarker results, and predicted disease progression among study participants.
Measured: Baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start14 Mar 2025
- Primary completion14 Dec 2025 (estimated)
- Study completion14 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MoCA Clinic and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- C2N Diagnostics
- Responsible party
- Sponsor
- Investigators
- Ziad Nasreddine, MD, Principal investigator, MoCA Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041450
- Sponsor's protocol ID
- : BBM-01-2025
- Status last verified
- Jun 2025
- First submitted
- 7 May 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Klil-Drori S, Bodenstein KC, Sun S, Kojok L, Gruber J, Ghantous Y, Cummings J, Nasreddine Z. Montreal Cognitive Assessment (MoCA) XpressO: Validation of a digital self-administered cognitive prescreening tool. J Am Geriatr Soc. 2024 Aug;72(8):2516-2522. doi: 10.1111/jgs.18902. Epub 2024 Apr 1.
PubMed 38558263
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Screening for Anti-amyloid Treatment Eligibility Using Digital Cognition and Blood-based Biomarkers
- ClinicalTrials.gov ID
- NCT07041450
- Acronym / sponsor ID
- : BBM-01-2025
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Dementia
- Keywords
- blood-based biomarkers, digital cognitive assessment, diagnostic screening, MoCA, disease-modifying therapy, older adults, early detection, Montreal Cognitive Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MoCA Clinic and InstituteUniversity, hospital or other
- Collaborators
- C2N Diagnostics
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 14 Dec 2025 (estimated)
- Study completion
- 14 Mar 2026 (estimated)
- First posted
- 27 Jun 2025 (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.
This study evaluates a diagnostic screening solution for Alzheimer's disease (AD) using digital cognitive assessments and blood-based biomarkers. The aim is to reduce time-to-treatment for patients who may benefit from disease-modifying therapy (DMT). The study involves 500 patients referred to the MoCA Clinic in Montreal. Clinical stages will be assessed using digital tools from MoCA Test Inc. (MoCA Cognition), and biological stages via blood biomarkers. Data collected includes demographics, cognitive scores, health questionnaires, biomarker levels, and neurologist-determined eligibility for DMT. The study will result in an algorithm to support diagnostic triage and estimate the efficiency and equity of a fast-track diagnostic pathway. Exploratory endpoints include validation of self-administered digital tools, health-economic estimates, and predictors of cognitive decline.
Detailed description
This study will evaluate a diagnostic screening solution based on clinical and biological stages of Alzheimer's disease (AD) ("Study"). The clinical stages will be screened using the digital tools from MoCA Test Inc. ("MoCA Cognition"). The biological stages will be screened using blood-based biomarkers ("BBM"). Based on the results of this Study, we will establish efficient and equitable criteria for diagnostic triage. The Study will result in an algorithm that can assist in assigning patients into a fast-track diagnostic pathway to determine if they are eligible or not for AD treatment with a disease modifying therapy ("DMT").
Primary objective: To develop and evaluate a diagnostic screening solution based on blood-based biomarkers and digital measures of cognition that could reduce the time-to-treatment for patients who are candidates for AD treatment with a disease modifying therapy.
Primary endpoint: Detailed cohort description of patients referred to the memory clinic MoCA Clinic Inc. ("MoCA Clinic"). This includes: (1) demographic characteristics; (2) cognitive screening scores measured by a digital MoCA via the MoCA score and XpressO application; (3) biomarker levels including PrecivityAD2 and MTBR; (4) the proportion of DMT candidates determined by a neurologist, (5) the causes and frequencies of why patients are not eligible for AD treatment (6) the number of diagnostic follow-up tests required after screening (MRI, PET/CSF), (7) the baseline referral times for future comparison against the fast-track pathway and (8) the time-until-diagnosis.
Secondary endpoints: Based on the primary endpoints, we will estimate the potential benefits of a diagnostic screening solution. This includes an estimation of the number of patients that would potentially miss out on the treatment window in the current diagnostic workflow.
Exploratory endpoints: (1) Validation of a self-administered digital version of the MoCA test ("MoCA Solo") compared to the paper MoCA test, (2) Evaluation of MoCA Solo as digital biomarker within the screening algorithm, (3) Health-economic estimation of the number and costs of follow-up tests at different levels of specificity, (4) The role of age, sex and education on the performance of the screening solution, (5) Prediction of time until patient would progress to moderate dementia based on baseline MoCA score and age, (6) Description of participant's history of symptoms and healthcare usage, (7) Correlation between the patient-centered version and the clinician versions of the Amyloid Treatment Screening Tool (ATST), (8) Evaluate the correlation between the MoCA Brain Health Questionnaire (MBHQ) score and participant diagnosis, (9) Evaluate the effect of the addition of MTBR results into screening algorithm.
Participants: Study population will include 500 patients who have been referred to the MoCA Clinic, including both new patients and existing patients. Based on prior referrals, we anticipate 60% female, 55-90 years, 80% French / 20% English, approximately 20% subjective cognitive decline (SCD), 60% mild cognitive impairment (MCI) and 20% mild dementia.
Study Location: The study is conducted as a single-center study with patients from the Montreal area. Patients will be enrolled at the MoCA Clinic where full informed consent will be obtained.
Study Visits: In the active study period, two MoCA Clinic visits will be planned within 1-3 months: Visit 1 includes data collection feasible at a primary care physician: digital cognitive assessments, blood sample collection and amyloid-treatment screening test. Visit 2 includes cognitive assessment, data collection and diagnosis typical for a neurological visit. After the blood sample is analyzed, the prediction of diagnosis and eligibility for DMT will be made using our algorithm. After the active study period, at 6 months, information from the medical records will be reviewed to evaluate clinical follow-up.
This study is supported by an independent research grant from Eli Lilly Canada Inc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational Cohort | – | Diagnostic Test: Digital MoCA, Diagnostic Test: XpressO, Diagnostic Test: MoCA, Diagnostic Test: Blood-based Biomarkers (BBM), Other: Amyloid Treatment Screening Tool (ATST), Other: MoCA Brain Health Questionnaire (MBHQ), Other: MoCA Medical Questionnaire, Other: Functional Activities Questionnaire+ (FAQ+)The study population will include 500 patients that have been referred to the MoCA Clinic from the Greater Montreal Area. This includes individuals with subjective cognitive decline (SCD), mild cognitive impairment (MCI), and mild dementia. Participants complete cognitive tests, health and cognition questionnaires, and undergo a blood test for blood biomarker testing. |
| Paper MoCA Subgroup | – | Diagnostic Test: Digital MoCA, Diagnostic Test: XpressO, Diagnostic Test: MoCA, Diagnostic Test: Blood-based Biomarkers (BBM), Other: Amyloid Treatment Screening Tool (ATST), Other: MoCA Brain Health Questionnaire (MBHQ), Other: MoCA Medical Questionnaire, Other: Functional Activities Questionnaire+ (FAQ+)Participants will be randomly assigned to complete either the paper MoCA or the digital MoCA Solo at Visit 1, with the other version completed at Visit 2. The Paper MoCA Subgroup will complete the paper MoCA at Visit 1. |
| MoCA Solo Subgroup | – | Diagnostic Test: Digital MoCA, Diagnostic Test: XpressO, Diagnostic Test: MoCA, Diagnostic Test: Blood-based Biomarkers (BBM), Other: Amyloid Treatment Screening Tool (ATST), Other: MoCA Brain Health Questionnaire (MBHQ), Other: MoCA Medical Questionnaire, Other: Functional Activities Questionnaire+ (FAQ+)Participants will be randomly assigned to complete either the paper MoCA or the digital MoCA Solo at Visit 1, with the other version completed at Visit 2. The MoCA Solo Subgroup will complete the MoCA Solo at Visit 1. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include 500 patients that have been referred to the MoCA Clinic from the Greater Montreal Area. There will be a mix of English and French speaking with approximately 80% having French as a first language.
Key inclusion criteria (4 listed)
- Must be referred to the MoCA Clinic; including both new patients and existing patients who have been seen >1 year ago
- Present with cognitive impairment or cognitive complaints.
- Must have the ability to understand the purpose and risk of the Study and provide informed consent.
- Must have an identified study partner (informant/care partner), who has frequent and sufficient contact with the participant to be able to provide accurate information about the participant's cognitive and functional abilities. The study partner must be available by phone to provide information to the study staff about the participant and agrees to attend one in-person visit at the MoCA Clinic which requires partner input. The study partner should be available for the duration of the study.
Key exclusion criteria (5 listed)
- An established diagnosis (other than AD), that is a cause for a candidate's cognitive impairment (e.g. substance abuse, cerebrovascular conditions, Lewy body dementia, fronto-temporal dementia, recent head trauma).
- Blood donation (1 unit) within 1 month prior to Study screening.
- Inability to comply with requirements to complete essential components of the Study (e.g. visual impairment, severe kidney disease or ongoing kidney treatment)
- Patients already enrolled in any clinical trial for AD at time of Study screening
- Other unspecified reasons that, in the opinion of the Principal Investigator, or MoCA Clinic and Institute, make the candidate unsuitable for enrolment.
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 |
|---|---|---|
| Digital MoCAAlso: MoCA SoloA digital version of the Montreal Cognitive Assessment used to evaluate cognitive function. Administered on a tablet at Visit 1 or Visit 2 (randomized). | Diagnostic test | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| XpressOA digital cognitive pre-screening tool used to screen for cognitive function. Administered on a tablet at Visit 1. | Diagnostic test | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| MoCAThe standard paper-baed Montreal Cognitive Assessment used to evaluate cognitive function. Administered at Visit 1 or Visit 2 (randomized), opposite the digital MoCA. | Diagnostic test | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| Blood-based Biomarkers (BBM)Participants provide a blood sample that is analyzed for Alzheimer's disease-related biomarkers, including PrecivityAD2 and MTBR. These biomarkers are used to assess the biological stage of disease and support diagnostic triage and eligibility assessment for disease-modifying therapy (DMT) | Diagnostic test | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| Amyloid Treatment Screening Tool (ATST)A questionnaire administered to assess eligibility for amyloid-targeted therapies. Both clinician and patient-centered versions are used. | Other | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| MoCA Brain Health Questionnaire (MBHQ)A questionnaire designed to capture participants' physical health, emotional well-being, diet, exercise, and social engagement as it relates to cognitive health. Responses are used as part of exploratory analyses to evaluate associations with cognitive status and Alzheimer's disease diagnosis. | Other | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| MoCA Medical QuestionnaireA structured questionnaire administered to participants to gather information on their medical history, including prior diagnoses, medications, and other health conditions. This data helps to contextualize cognitive symptoms and support diagnostic decision-making in the study. | Other | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
| Functional Activities Questionnaire+ (FAQ+)A questionnaire designed to assess the participant's ability to perform daily activities, providing insights into their functional status and cognitive impairment. It is a longer version of the original FAQ questionnaire. It is used as part of the screening and exploratory analysis to better understand the relationship between functional abilities and Alzheimer's disease progression. | Other | MoCA Solo Subgroup, Observational Cohort, Paper MoCA Subgroup |
Primary outcome
Time to diagnosis
Time frame: From enrollment to 6-month follow-up
The primary outcome metric is the time to diagnosis for patients that are eligible vs. not eligible for anti-amyloid medication. In this case, time to diagnosis is defined by the time it takes to determine if patient is eligible anti-amyloid medication or not.
1 secondary outcome
Benefit of Diagnostic Screening
Time frame: Baseline to 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Results publication: PubMed 38558263Klil-Drori S, Bodenstein KC, Sun S, Kojok L, Gruber J, Ghantous Y, Cummings J, Nasreddine Z. Montreal Cognitive Assessment (MoCA) XpressO: Validation of a digital self-administered cognitive prescreening tool. J Am Geriatr Soc. 2024 Aug;72(8):2516-2522. doi: 10.1111/jgs.18902. Epub 2024 Apr 1.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Ziad Nasreddine, MD principal investigator
MoCA Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by MoCA Clinic and Institute at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanna Gruber, MSc (5147585033, johanna.gruber@mocacognition.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis (time frame: From enrollment to 6-month follow-up). 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 NCT07041450, which also lists 1 linked publication.
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 1 Jul 2025.