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

NCT07804771 | Not Yet Recruiting

• 2 other identifiers: 2026-A00859-4200159760
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Accidental Falls

Outcome Measures

Primary Outcomes (1)

• Stable Candidate Multimodal Biomarkers Discriminating Participants With and Without Prior Falls

  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.

  Baseline assessment

Secondary Outcomes (1)

• Predictive Performance of Baseline Biomarkers for Incident Falls

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

Study Arms (2)

Prior Fall History

Community-dwelling adults aged 65 years or older who experienced at least one fall during the 12 months before enrollment. Participants undergo the same multimodal baseline assessments and 12-month prospective fall monitoring as the other cohort. No intervention is assigned.

No Prior Fall History

Community-dwelling adults aged 65 years or older who experienced no falls during the 12 months before enrollment. Participants undergo the same multimodal baseline assessments and 12-month prospective fall monitoring as the other cohort. No intervention is assigned.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling adults aged 65 years who meet the study eligibility criteria. The study will recruit 100 participants: 50 who experienced at least one fall during the 12 months before enrollment and 50 who experienced no falls during that period. All participants will undergo the same baseline assessments and prospective 12-month fall monitoring.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Slb Pharma: lead
• Université de Caen Normandie: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Fasting blood samples, including whole blood collected in K2-EDTA tubes for genomic DNA extraction and single-nucleotide polymorphism analysis. Plasma, serum, and dedicated blood samples will also be collected for proteomic, transcriptomic, cytokine, targeted biomarker, and clinical chemistry analyses. Samples will be processed and stored at -80°C.

Central Study Contacts

Antoine Langeard, PhD

CONTACT

+332 31 56 82 24; antoine.langeard@unicaen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share