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Falls: A Marker of Preclinical AD

Falls: A Marker of Preclinical Alzheimer Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04949529
Enrollment
355
Registered
2021-07-02
Start date
2019-03-07
Completion date
2025-04-30
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Fall

Keywords

Preclinical Alzheimer Disease, Falls, Functional Mobility, Older Adults

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 65 years of age or older 2. 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. 3. 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.

Design outcomes

Primary

MeasureTime frameDescription
Fall SeverityPer 12 month time periodProspective monthly fall reporting was collected using an automated phone/email system. Severity of falls was calculated using a previously published algorithm.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSusan L Stark, PhD

Washington University School of Medicine

PRINCIPAL_INVESTIGATORBeau Ances, MD, PhD, MSc

Washington University School of Medicine

Participant flow

Recruitment details

Participants were recruited on a rolling basis and assessed annually for up to four years during the project period. Some participants did not complete all four years of assessments due to being recruited and enrolled later in the project period.

Baseline characteristics

Characteristic
Age, Continuous74.1 years
STANDARD_DEVIATION 5.9
Education16.6 years
STANDARD_DEVIATION 2.4
Preclinical AD status
Preclinical AD negative
192 Participants
Preclinical AD status
Preclinical AD positive
102 Participants
Race/Ethnicity, Customized
Black/African American
44 Participants
Race/Ethnicity, Customized
More than one race
2 Participants
Race/Ethnicity, Customized
White
309 Participants
Sex: Female, Male
Female
208 Participants
Sex: Female, Male
Male
147 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
13 / 355
other
Total, other adverse events
0 / 355
serious
Total, serious adverse events
0 / 355

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026