Trial Outcomes & Findings for Falls: A Marker of Preclinical AD (NCT NCT04949529)

Last Updated: 2026-07-22

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

355 participants

Primary outcome timeframe

Per 12 month time period

Results posted on

2026-07-22

Participant Flow

Participants were recruited on a rolling basis and assessed annually for up to four years during the project period. Some participants did not complete all four years of assessments due to being recruited and enrolled later in the project period.

Participant milestones

Participant milestones
Measure	Cohort Community-dwelling cognitively normal (Clinical Dementia Rating=0) older adults (65 years of age and older) currently enrolled in longitudinal studies of memory and aging.
Year 1 STARTED	355
Year 1 COMPLETED	355
Year 1 NOT COMPLETED	0
Year 2 STARTED	355
Year 2 COMPLETED	349
Year 2 NOT COMPLETED	6
Year 3 STARTED	349
Year 3 COMPLETED	262
Year 3 NOT COMPLETED	87
Year 4 STARTED	262
Year 4 COMPLETED	204
Year 4 NOT COMPLETED	58

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biomarker data was not available for all participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort n=355 Participants Community-dwelling cognitively normal (Clinical Dementia Rating=0) older adults (65 years of age and older) currently enrolled in longitudinal studies of memory and aging.
Age, Continuous	74.1 years STANDARD_DEVIATION 5.9 • n=355 Participants
Sex: Female, Male Female	208 Participants n=355 Participants
Sex: Female, Male Male	147 Participants n=355 Participants
Race/Ethnicity, Customized Black/African American	44 Participants n=355 Participants
Race/Ethnicity, Customized White	309 Participants n=355 Participants
Race/Ethnicity, Customized More than one race	2 Participants n=355 Participants
Education	16.6 years STANDARD_DEVIATION 2.4 • n=355 Participants
Preclinical AD status Preclinical AD positive	102 Participants n=294 Participants • Biomarker data was not available for all participants.
Preclinical AD status Preclinical AD negative	192 Participants n=294 Participants • Biomarker data was not available for all participants.

PRIMARY outcome

Timeframe: Per 12 month time period

Population: Participants who completed 12 months of fall monitoring each year

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

Outcome measures

Outcome measures
Measure	Cohort n=349 Participants Community-dwelling cognitively normal (Clinical Dementia Rating=0) older adults (65 years of age and older) currently enrolled in longitudinal studies of memory and aging.
Fall Severity Year 1 · >= one fall causing serious injury / ER visit	15 Participants
Fall Severity Year 1 · No falls	155 Participants
Fall Severity Year 1 · One fall without serious injury	100 Participants
Fall Severity Year 2 · No falls	107 Participants
Fall Severity Year 2 · One fall without serious injury	59 Participants
Fall Severity Year 2 · >one fall without serious injury	65 Participants
Fall Severity Year 2 · >= one fall causing serious injury / ER visit	11 Participants
Fall Severity Year 3 · No falls	95 Participants
Fall Severity Year 3 · One fall without serious injury	44 Participants
Fall Severity Year 3 · >one fall without serious injury	53 Participants
Fall Severity Year 3 · >= one fall causing serious injury / ER visit	15 Participants
Fall Severity Year 4 · No falls	77 Participants
Fall Severity Year 4 · One fall without serious injury	54 Participants
Fall Severity Year 4 · >one fall without serious injury	48 Participants
Fall Severity Year 4 · >= one fall causing serious injury / ER visit	8 Participants
Fall Severity Year 1 · >one fall without serious injury	79 Participants

Adverse Events

Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 13 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susy Stark

Washington University

Phone: (314) 935-2551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place