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Completed

NCT Number: NCT04949529

Falls: A Marker of Preclinical AD

This longitudinal cohort study investigates cognitively normal participants with and without preclinical Alzheimer disease (AD) in order to examine: (1) the relationship between falls and functional mobility in preclinical stages of AD; and (2) a hypothesized model of central and peripheral mechanism(s) underlying falls and functional mobility in preclinical stages of AD.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

Alzheimer disease (AD) is a slowly progressive neurodegenerative disease. Conversion to symptomatic AD occurs slowly over years through a series of preclinical stages marked by changes in molecular biomarkers. It is unknown whether functional mobility and falls are preclinical markers of AD.

This longitudinal clinical study evaluates a cohort of cognitively normal individuals who are currently undergoing comprehensive clinical, neuropsychological, and biomarker evaluations at the Knight Alzheimer's Disease Research Center (Knight ADRC). They receive an annual in-home evaluation of fall risks and functional mobility and prospective ascertainment of falls. Comparisons of assessments of functional mobility will be performed with regard to measures of brain pathology (i.e., amyloidosis, tau, and neurodegeneration) to allow researchers to characterize when changes in falls and functional mobility occur during preclinical stages of AD.

This study also examines the central and peripheral system mechanism(s) underlying falls and functional mobility in preclinical AD using structural equation modeling.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65 years of age or older
  • cognitively normal (Clinical Dementia Rating [CDR] score of 0)
  • A pilot sub-study collecting stool will also enroll a few individuals with CDR>0 for comparison.
  • have biomarkers (CSF), and/or neuroimaging (positron emission tomography [PET] and/or magnetic resonance imaging [MRI]) within 2 years of enrolling in this study.

Exclusion criteria

  • History of Parkinson's disease.

Treatment and study plan

Primary outcomes

  1. Fall Severity

    Time frame: Per 12 month time period

    Prospective monthly fall reporting was collected using an automated phone/email system. Severity of falls was calculated using a previously published algorithm.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Falls: A Marker of Preclinical Alzheimer Disease

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2021
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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