FallNCT04949529
Falls: A Marker of Preclinical AD
An observational study of Fall and Alzheimer Disease, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Alzheimer Disease
- How many people
- 355 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 30 Apr 2025
- Phase
- Observational
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: A cohort of cognitively normal community-dwelling older adults who are currently undergoing comprehensive clinical, neuropsychological, and biomarker evaluations at the Knight Alzheimer's Disease Research Center (Knight ADRC) at Washington University in St. Louis.
Who may be able to join
- 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.
Who cannot join
- History of Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Falls: A Marker of Preclinical Alzheimer Disease
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.
Read the 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.
- Conditions
- Fall, Alzheimer Disease
- Keywords
- Preclinical Alzheimer Disease, Falls, Functional Mobility, Older Adults
- Medical subject headings
- Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Severity
Prospective monthly fall reporting was collected using an automated phone/email system. Severity of falls was calculated using a previously published algorithm.
Note that this was an observational study with no intervention. No primary or secondary outcome measures were pre-specified; thus we report descriptive data on fall severity, one of the main measures that was collected over time.
Measured: Per 12 month time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start7 Mar 2019
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Susan Stark, Washington University School of Medicine
- Investigators
- Susan L Stark, PhD, Principal investigator, Washington University School of MedicineBeau Ances, MD, PhD, MSc, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949529
- Sponsor's protocol ID
- 201807135
- Other IDs
- R01AG057680-01A1
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2021
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bollinger RM, Keleman A, Thompson R, Westerhaus E, Fagan AM, Benzinger TL, Schindler SE, Xiong C, Balota D, Morris JC, Ances BM, Stark SL. Falls: a marker of preclinical Alzheimer disease: a cohort study protocol. BMJ Open. 2021 Sep 15;11(9):e050820. doi: 10.1136/bmjopen-2021-050820.
PubMed 34526343