Falls: A Marker of Preclinical AD

NCT04949529 | Completed Results

• 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 (1)

• Fall Severity

  Prospective monthly fall reporting was collected using an automated phone/email system. Severity of falls was calculated using a previously published algorithm.

  Per 12 month time period

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

Results Point of Contact

• Title: Susy Stark
• Organization: Washington University

sstark@wustl.edu

(314) 935-2551

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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 22, 2026
• Results First Posted: July 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)