Accidental FallsPrediFallNCT07804771
Polymodal Fall Prediction in Healthy Older Adults: Clinical, Laboratory, and Blood-Based Biomarkers
An observational study of Accidental Falls, run by Slb Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
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- hospitalization within the past 30 days,
- participation in another clinical study,
- unable or unwilling to provide informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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?
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment
Secondary outcomes (1)
Predictive Performance of Baseline Biomarkers for Incident Falls
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.
Measured: From completion of baseline assessments through 12 months of prospective follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slb Pharma
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Caen Normandie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804771
- Sponsor's protocol ID
- 2026-A00859-42
- Other IDs
- 00159760
- Acronym
- PrediFall
- Status last verified
- Sep 2026
- First submitted
- 7 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be made available through a publicly accessible data repository after completion of the study and publication of the main results, subject to institutional, ethical, and data protection requirements. Genetic and genomic individual participant data will not be made publicly available because of privacy, ethical, and data protection considerations.