Falls: A Marker of Preclinical AD

The Washington University

Status: Completed

Conditions: Alzheimer Disease; Fall

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04949529

201807135

R01AG057680-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.