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NCT Number: NCT07804771

Polymodal Fall Prediction in Healthy Older Adults: Clinical, Laboratory, and Blood-Based Biomarkers

The goal of this observational study is to identify clinical, laboratory, and biological markers associated with past (and future falls) in healthy older adults aged 65 years and over.

The main question it aims to answer is: Which clinical, functional, laboratory, and blood-based markers distinguish older adults who have fallen at least once during the previous 12 months from those who have not?

Researchers will compare older adults with a history of falls with similar older adults without a history of falls. One hundred healthy older adults aged 65 and over, including both fallers and non-fallers, will be recruited for the study.

Participants will complete questionnaires and undergo cognitive and physical tests, physical activity and sleep monitoring, gait, balance, muscle, sensory and vestibular assessments, brain and muscle imaging, and blood sampling. Blood samples will be used to study proteins and genetic variants that may be associated with falls. Participants will then be followed for one year using a smartphone-based application to report falls.

The study is based on the hypothesis that a history of falling in an otherwise healthy older adult may be associated with subtle clinical, functional, and biological differences compared with a similar older adult without a history of falls. The findings may support the future development of more accurate and scalable tools for early fall-risk detection and targeted fall-prevention strategies. No direct therapeutic benefit is expected from participation.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being aged ≥65 years,
  • having independent ambulation,
  • having an Mini Mental State Examination (MMSE) score ≥24,
  • being fluent in French,
  • being affiliated with the national social security system,
  • providing written informed consent.

Exclusion criteria

  • neurological or psychiatric disorders affecting motor or cognitive function (e.g., Parkinson's disease, stroke sequelae, major depression) or other severe comorbidities that could affect participant safety and study outcomes,
  • recent lower-limb surgery (<12 months),
  • polypharmacy (use of more than four medications) or fall-risk increasing drugs,
  • significant sensory impairments limiting assessment,
  • immune-related conditions or recent infections,
  • contraindications to MRI,
  • hospitalization within the past 30 days,
  • participation in another clinical study,
  • unable or unwilling to provide informed consent.

Treatment and study plan

Primary outcomes

  1. Stable Candidate Multimodal Biomarkers Discriminating Participants With and Without Prior Falls

    Time frame: Baseline assessment

    The outcome will be the number and identity of stable candidate biomarkers that discriminate participants who experienced at least one fall during the previous 12 months from participants who experienced no falls during that period.

Secondary outcomes

  1. Predictive Performance of Baseline Biomarkers for Incident Falls

    Time frame: From completion of baseline assessments through 12 months of prospective follow-up

    The ability of baseline biomarkers retained by the stability-selection procedure to predict at least one incident fall during prospective follow-up will be evaluated. Predictive performance will be reported using the area under the receiver operating characteristic curve, sensitivity, and specificity, each with 95% confidence intervals.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Langeard, PhD

CONTACT

[email protected]

+332 31 56 82 24

Sponsors and collaborators

Lead sponsor

Slb Pharma

Other

Collaborators

  • Université de Caen Normandie

Registry information

Acronym: PrediFall

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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