Sex-specific Risk Factors and Trajectories of Blood Biomarkers for Alzheimer's Disease and Related Dementias

NCT07224139 | Active Not Recruiting

• 1 other identifier: 1RF1AG079397
• Study Type: observational
• Target: 13,435
• Locations: 2 countries
• Sites: 5

Brief 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 clinical trials.

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  In a community population of 21,000 older persons without dementia, we will measure changes in these biomarkers over 7 to 10 years

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Anne Murray: lead

Study Sites (5)

Foundation for Atlanta Veterans Education and Research, Inc.

Decatur, Georgia, 30033, United States

Location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

Regents of the University of Minnesota - Advanced Research & Diagnostic

Minneapolis, Minnesota, 55455, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Monash University

Melbourne, Victoria, 3800, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood.

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Anne Murray, MD, MSc

  Hennepin Healthcare Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: July 1, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-09

Locations

AU (1); US (4)