Falls: A Marker of Preclinical AD

NCT04949529 | Completed

• 2 other identifiers: 201807135R01AG057680-01A1
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall; Alzheimer Disease

Keywords

Preclinical Alzheimer Disease; Falls; Functional Mobility; Older Adults

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Change from baseline: Gait Speed

  Gait speed will be collected using the Timed Up and Go (TUG) test.

  4 years post-enrollment

• 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 Outcomes (11)

• Fall Risk Composite Score

  4 years post-enrollment

• Change from baseline: Standing balance and vestibular function

  4 years post-enrollment

• Change from baseline: Lower extremity strength

  4 years post-enrollment

• Change from baseline: Grip strength

  4 years post-enrollment

• Change from baseline: Vision

  4 years post-enrollment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• History of Parkinson's disease.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 34526343 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. Whole blood sample 2. Cerebral spinal fluid (CSF) 3. Stool

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Susan L Stark, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Beau Ances, MD, PhD, MSc

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Occupational Therapy, Neurology, and Social Work

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: July 2, 2021
• Study Start: March 7, 2019
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)