Falls: A Marker of Preclinical AD

Alzheimer Disease Clinical Trial

Official title:

Falls: A Marker of Preclinical Alzheimer Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04949529
• Other study ID #: 201807135
• Secondary ID: R01AG057680-01A1
• Status: Enrolling by invitation
• Start date: March 7, 2019
• Est. completion date: April 2025

Study information

• Verified date: August 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 falls and functional mobility in preclinical stages of AD.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 350
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Fall

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Severity of Falls	Prospective monthly fall reporting will be collected using an automated phone/email system. Severity of falls will be calculated using a previously published algorithm.	Cumulative falls at 4 years post-enrollment
Primary	Change from baseline: Dynamic balance and mobility	Dynamic balance and mobility will be assessed using the Performance Oriented Mobility Assessment (POMA), a task-oriented assessment.	4 years post-enrollment
Primary	Change from baseline: Gait Speed	Gait speed will be collected using the Timed Up and Go (TUG) test.	4 years post-enrollment
Primary	Change from baseline: Dual-task gait	Dual-task gait will be collected using the Timed Up and Go Cognitive (TUGcog) and Timed Up and Go Manual (TUGman)	4 years post-enrollment
Secondary	Fall Risk Composite Score	A fall risk composite score will be calculated using established cut-off values, dichotomized as 0 (no risk), or 1 (fall risk), and summed. Higher score indicate higher fall risk. Constructs that will be included are: vision, alcohol abuse, urinary incontinence, depression, pain, medication, functional capacity with activities of daily living, previous falls, home hazards, and self-efficacy.	4 years post-enrollment
Secondary	Change from baseline: Standing balance and vestibular function	Center of pressure path will be measured using Balance Tracking System (BTrackS)	4 years post-enrollment
Secondary	Change from baseline: Lower extremity strength	Lower extremity strength will be assessed using the 30-Second Chair Stand test and minimal change in the peak torque value	4 years post-enrollment
Secondary	Change from baseline: Grip strength	Pounds of force will be measured using a handheld dynamometer	4 years post-enrollment
Secondary	Change from baseline: Vision	Visual acuity will be collected using the Early Treatment Diabetic Retinopathy Study (ETDRS) test, and contrast sensitivity will be measured using the Pelli-Robson test	4 years post-enrollment
Secondary	Change from baseline: Sensation	8-item questionnaire and sensation testing (vibration [feet] and sharp [arms and legs])	4 years post-enrollment
Secondary	Change from baseline: Depression	Frequency of symptoms will be assessed using The Patient Health Questionnaire (PHQ-9) and Geriatric Depression Scale (GDS)	4 years post-enrollment
Secondary	Change in baseline: Functional performance	Independence, safety, and adequacy with shopping, checkbook balancing, and medication management will be assessed using the Performance Assessment of Self-Care Skills (PASS)	4 years post-enrollment
Secondary	Change from baseline: Falls behavior	Behaviors to prevent falls will be measured using the Falls Behavioral Scale for Older People (FaB)	4 years post-enrollment
Secondary	Change from baseline: Olfaction	Olfaction will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT)	2 years post-enrollment
Secondary	Change from baseline: Hearing	Hearing impairment will be assessed using The Hearing Handicap Inventory for the Elderly (HHIE-S)	4 years post-enrollment