Alzheimer's Disease (AD)BioMINDNCT06843109
Biomarkers in a Candian Memory Clinic
An observational study of Alzheimer's Disease (AD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a prospective, observational, case control study in a real-world cohort of patients referred by a primary care physician to a tertiary memory clinic for cognitive concerns. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jun 2024to Sep 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 participants will be included from referrals to the Aging Brain and Memory Clinic or Cognitive Neurology. Study investigators will use the CSF and PET scan results to complete the respective surveys. This is a convenience sample so there is not a statistical difference in the number of samples selected as part of this study.
Who may be able to join
- Individual with MCI (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
- MoCA score must be 18 to 28 inclusive
- Age 55 to 80 years inclusive
- Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
- Group A - must have a clinical memory assessment appointment scheduled at Parkwood Institute within 18 months of baseline
- Group B - must have had a clinical memory assessment appointment at Parkwood Institute within 18 months of baseline
Who cannot join
- 1) Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc).
- 2) Presence of any neurological, psychiatric, or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including, but not limited to, pre-manifest Huntington's disease, multiple sclerosis, Parkinson's disease, Down's syndrome, active alcohol/drug abuse or major psychiatric disorders including, but not limited to, schizophrenia, schizoaffective disorder, or bipolar affective disorder or current episode of major depressive disorder.
- 3) Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures 4) History of epilepsy, fits, or unexplained blackouts other than vasovagal syncope within 10 years before screening.
- 5) Malignant neoplasms within 3 years (except for basal cell or squamous cell carcinoma in situ of the skin) 6) Women of child bearing potential and breastfeeding mothers 7) Individuals who require sedation to complete PET scan. 8) Individuals who are unable to complete assessments in the English language. 9) Individuals who cannot provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biomarkers as Part of Diagnostic Workup for Alzheimer's Disease: A Feasibility Study in a Canadian Memory Clinic
This is a prospective, observational, case control study in a real-world cohort of patients referred by a primary care physician to a tertiary memory clinic for cognitive concerns. This study's main objective is to determine the effect of using standardized criteria (based on eligibility for disease modifying treatment (DMT)) to triage patients towards biological staging of disease with biomarker testing.
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- mild cognitive impairment, dementia, biomarkers
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Participants who have not yet completed assessment at Parkwood Institute for memory concerns | |
| Group B | Participants who have completed assessment at Parkwood Institute for memory concerns. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD.
Analysis of resources needed to conduct testing including personnel required, time requirements, space, and resources/equipment
Measured: through study completion, approximately 1 year
Secondary outcomes (2)
Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm.
Measured by investigator pre and post biomarker questionnaire indicating clinical suspicion, confidence of clinical suspicion, tests to be ordered, and management plan.
Measured: through study completion, approximately one year
Evaluate the impact of biomarker results on participants
Determined by Participant Pre and Post Biomarker Questionnaire
Measured: through study completion, approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start11 Jun 2024
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Parkwood Hospital, London, Ontario
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843109
- Sponsor's protocol ID
- BioMIND
- Acronym
- BioMIND
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers as Part of Diagnostic Workup for Alzheimer's Disease: A Feasibility Study in a Canadian Memory Clinic
- ClinicalTrials.gov ID
- NCT06843109
- Acronym / sponsor ID
- BioMIND / BioMIND
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- mild cognitive impairment, dementia, biomarkers
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Parkwood Hospital, London, Ontario
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 24 Feb 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 is a prospective, observational, case control study in a real-world cohort of patients referred by a primary care physician to a tertiary memory clinic for cognitive concerns. This study's main objective is to determine the effect of using standardized criteria (based on eligibility for disease modifying treatment (DMT)) to triage patients towards biological staging of disease with biomarker testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –Participants who have not yet completed assessment at Parkwood Institute for memory concerns |
| Group B | – | –Participants who have completed assessment at Parkwood Institute for memory concerns. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 participants will be included from referrals to the Aging Brain and Memory Clinic or Cognitive Neurology. Study investigators will use the CSF and PET scan results to complete the respective surveys. This is a convenience sample so there is not a statistical difference in the number of samples selected as part of this study.
Key inclusion criteria (6 listed)
- Individual with MCI (if not yet diagnosed, individuals with amnestic changes in memory as shown on MoCA)
- MoCA score must be 18 to 28 inclusive
- Age 55 to 80 years inclusive
- Has a study partner that is willing to participate as a source of information and has approximately weekly contact with the subject (contact can be in-person, via telephone or electronic communication). The study partner must have sufficient contact such that the investigator feels the study partner can provide meaningful information about the subject's daily function.
- Group A - must have a clinical memory assessment appointment scheduled at Parkwood Institute within 18 months of baseline
Key exclusion criteria (4 listed)
- 1) Participants who fulfill diagnostic criteria for MCI or dementia/mild or major neurocognitive disorder suspected to be due to any etiology other than AD (eg, MCI/dementia due to frontotemporal lobar degeneration, diffuse Lewy body disease, Parkinson's disease, cerebrovascular disease, normal pressure hydrocephalus, head injury, drug or alcohol abuse/dependence, anoxic brain injury, etc).
- 2) Presence of any neurological, psychiatric, or medical conditions associated with a long-term risk of significant cognitive impairment or dementia including, but not limited to, pre-manifest Huntington's disease, multiple sclerosis, Parkinson's disease, Down's syndrome, active alcohol/drug abuse or major psychiatric disorders including, but not limited to, schizophrenia, schizoaffective disorder, or bipolar affective disorder or current episode of major depressive disorder.
- 3) Current or history within the past 2 years of psychiatric diagnosis or symptoms (eg, hallucinations, major depression, or delusions) that, in the opinion of the investigator, could interfere with study procedures 4) History of epilepsy, fits, or unexplained blackouts other than vasovagal syncope within 10 years before screening.
- 5) Malignant neoplasms within 3 years (except for basal cell or squamous cell carcinoma in situ of the skin) 6) Women of child bearing potential and breastfeeding mothers 7) Individuals who require sedation to complete PET scan. 8) Individuals who are unable to complete assessments in the English language. 9) Individuals who cannot provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD.
Time frame: through study completion, approximately 1 year
Analysis of resources needed to conduct testing including personnel required, time requirements, space, and resources/equipment
2 secondary outcomes
Evaluate the clinical utility of CSF and PET biomarkers in the diagnostic algorithm.
Time frame: through study completion, approximately one year
Evaluate the impact of biomarker results on participants
Time frame: through study completion, approximately one year
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 24 Feb 2025.
- Individual participant dataSharing planned: No. Individual Participant Data will only be available to local site. All study results and conclusions from the study will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Alzheimer's Disease (AD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 24 Feb 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?
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?
Determine the feasibility of integrating a CSF biomarker into diagnostic decision making for AD. (time frame: through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.