Clinical trial NCT04949529: Falls: A Marker of Preclinical AD
Official title: Falls: A Marker of Preclinical Alzheimer Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Fall
Alzheimer Disease
Keywords: Preclinical Alzheimer Disease
Falls
Functional Mobility
Older Adults
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-07-02
Enrollment: 350
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and Severity of Falls
timeFrame: Cumulative falls at 4 years post-enrollment
measure: Change from baseline: Dynamic balance and mobility
timeFrame: 4 years post-enrollment
measure: Change from baseline: Gait Speed
timeFrame: 4 years post-enrollment
measure: Change from baseline: Dual-task gait
timeFrame: 4 years post-enrollment
Secondary outcomes:
measure: Fall Risk Composite Score
timeFrame: 4 years post-enrollment
measure: Change from baseline: Standing balance and vestibular function
timeFrame: 4 years post-enrollment
measure: Change from baseline: Lower extremity strength
timeFrame: 4 years post-enrollment
measure: Change from baseline: Grip strength
timeFrame: 4 years post-enrollment
measure: Change from baseline: Vision
timeFrame: 4 years post-enrollment
measure: Change from baseline: Sensation
timeFrame: 4 years post-enrollment
measure: Change from baseline: Depression
timeFrame: 4 years post-enrollment
measure: Change in baseline: Functional performance
timeFrame: 4 years post-enrollment
measure: Change from baseline: Falls behavior
timeFrame: 4 years post-enrollment
measure: Change from baseline: Olfaction
timeFrame: 2 years post-enrollment
measure: Change from baseline: Hearing
timeFrame: 4 years post-enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Susan L Stark, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Beau Ances, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.