Alzheimer DiseaseNCT07224139
Sex-specific Risk Factors and Trajectories of Blood Biomarkers for Alzheimer's Disease and Related Dementias
An observational study of Alzheimer Disease and Dementia, run by Anne Murray at 5 sites in 2 countries.
Trial summary
Blood-based ADRD biomarkers show tremendous promise as a non-invasive method to predict and diagnose ADRD. We will measure changes in these biomarkers to determine whether their ability to predict ADRD differs by sex or by other characteristics, and develop a sex-specific ADRD risk score for personalized medicine and… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Cognitive Dysfunction
- How many people
- 13,435 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 2022to Aug 2027
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The data and biospecimens collected for a large-scale study of initially healthy individuals aged 65-98 years from the US and Australia (12,716 whites, 412 blacks, 339 other minorities) with comprehensive annual in-person cognitive assessments, adjudicated clinical outcomes, detailed data on socio-economic status, lifestyle and health factors collected over a median 9+ years, and existing genetic data (APOE4, dementia polygenic risk scores).
Who may be able to join
- We will use de-identified data and biospecimens originally collected for a large binational NIA-funded ASPirin in Reducing Events in the Elderly (ASPREE) randomized clinical trial and ongoing observational follow-up (U19 AG062682) for analysis.
Who cannot join
- None
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Foundation for Atlanta Veterans Education and Research, Inc.
Decatur, Georgia, 30033
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
Regents of the University of Minnesota - Advanced Research & Diagnostic
Minneapolis, Minnesota, 55455
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Blood-based ADRD biomarkers show tremendous promise as a non-invasive method to predict and diagnose ADRD. We will measure changes in these biomarkers to determine whether their ability to predict ADRD differs by sex or by other characteristics, and develop a sex-specific ADRD risk score for personalized medicine and clinical trials.
Read the detailed description
Late-life Alzheimer's disease and related dementias (ADRD) are devastating multifactorial conditions and the major contributors to loss of independence in older age. There is a critical unmet need to identify which individuals are at the great risk of these conditions, thus permitting accurate prognosis and timely preventative interventions to reduce the burden. Yet, while a number of risk factors have been identified for these conditions, sex differences in these associations have rarely been considered. Furthermore, exciting recent advances in blood amyloid, tau and neurodegeneration (AT(N)) biomarkers for ADRD means that they could soon be used as powerful clinical diagnostic and prognostic tools in a personalized medicine approach. However, a number of critical knowledge gaps remain. Importantly, 1) these biomarkers have not been sufficiently examined in longitudinal studies of older community- based populations without diagnosed dementia; 2) it is unclear how participant characteristics such as comorbidities affect the clinical interpretation of these biomarkers; and 3) how their interpretation may differ between men and women. Together, these large knowledge gaps highlight a crucial need to develop the first sex-specific risk score for ADRD that incorporates blood AT(N) biomarkers and ADRD risk factors.
- Conditions
- Alzheimer Disease, Dementia, Cognitive Dysfunction
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively measure plasma AT(N) biomarkers and to identify participant characteristics that are associated with these levels separately in women and men.
We hypothesize that:
1a. There will be sex differences in the cross-sectional biomarker levels, and in their trajectories over time.
1b. Chronic comorbidities and genetic risk factors (APOE ε4, polygenic risk score) will be associated with 'worse' AT(N) biomarker levels (reflecting worse ADRD pathology) at baseline and with a greater increase over time over time, and that these associations will differ between men and women.
Measured: In a community population of 21,000 older persons without dementia, we will measure changes in these biomarkers over 7 to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2025
- Study start1 Jul 2022
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- 13,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Murray
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Murray, Hennepin Healthcare Research Institute
- Investigators
- Anne Murray, MD, MSc, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224139
- Sponsor's protocol ID
- 1RF1AG079397
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2025
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-specific Risk Factors and Trajectories of Blood Biomarkers for Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT07224139
- Acronym / sponsor ID
- 1RF1AG079397
- Conditions
- Alzheimer Disease, Dementia, Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 13,435 participants (actual)
- Lead sponsor
- Anne MurrayUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Nov 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.
Blood-based ADRD biomarkers show tremendous promise as a non-invasive method to predict and diagnose ADRD. We will measure changes in these biomarkers to determine whether their ability to predict ADRD differs by sex or by other characteristics, and develop a sex-specific ADRD risk score for personalized medicine and clinical trials.
Detailed description
Late-life Alzheimer's disease and related dementias (ADRD) are devastating multifactorial conditions and the major contributors to loss of independence in older age. There is a critical unmet need to identify which individuals are at the great risk of these conditions, thus permitting accurate prognosis and timely preventative interventions to reduce the burden. Yet, while a number of risk factors have been identified for these conditions, sex differences in these associations have rarely been considered. Furthermore, exciting recent advances in blood amyloid, tau and neurodegeneration (AT(N)) biomarkers for ADRD means that they could soon be used as powerful clinical diagnostic and prognostic tools in a personalized medicine approach. However, a number of critical knowledge gaps remain. Importantly, 1) these biomarkers have not been sufficiently examined in longitudinal studies of older community- based populations without diagnosed dementia; 2) it is unclear how participant characteristics such as comorbidities affect the clinical interpretation of these biomarkers; and 3) how their interpretation may differ between men and women. Together, these large knowledge gaps highlight a crucial need to develop the first sex-specific risk score for ADRD that incorporates blood AT(N) biomarkers and ADRD risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The data and biospecimens collected for a large-scale study of initially healthy individuals aged 65-98 years from the US and Australia (12,716 whites, 412 blacks, 339 other minorities) with comprehensive annual in-person cognitive assessments, adjudicated clinical outcomes, detailed data on socio-economic status, lifestyle and health factors collected over a median 9+ years, and existing genetic data (APOE4, dementia polygenic risk scores).
Key inclusion criteria (1 listed)
- We will use de-identified data and biospecimens originally collected for a large binational NIA-funded ASPirin in Reducing Events in the Elderly (ASPREE) randomized clinical trial and ongoing observational follow-up (U19 AG062682) for analysis.
Key exclusion criteria (1 listed)
- None
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
To prospectively measure plasma AT(N) biomarkers and to identify participant characteristics that are associated with these levels separately in women and men.
Time frame: In a community population of 21,000 older persons without dementia, we will measure changes in these biomarkers over 7 to 10 years
We hypothesize that: 1a. There will be sex differences in the cross-sectional biomarker levels, and in their trajectories over time. 1b. Chronic comorbidities and genetic risk factors (APOE ε4, polygenic risk score) will be associated with 'worse' AT(N) biomarker levels (reflecting worse ADRD pathology) at baseline and with a greater increase over time over time, and that these associations will differ between men and women.
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 4 Nov 2025.
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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. This study is not recruiting at the moment.
Anne Murray, MD, MSc principal investigator
Hennepin Healthcare Research Institute
5 sites in 2 countries: 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 Anne Murray at 5 sites in 2 countries.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. 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?
To prospectively measure plasma AT(N) biomarkers and to identify participant characteristics that are associated with these levels separately in women and men. (time frame: In a community population of 21,000 older persons without dementia, we will measure changes in these biomarkers over 7 to 10 years). 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 4 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.