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
- Are there results?
- Not yet: the study is under way
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,
Show all 9Show fewer
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymodal Fall Prediction in Healthy Older Adults: Clinical, Laboratory, and Blood-Based Biomarkers
- ClinicalTrials.gov ID
- NCT07804771
- Acronym / sponsor ID
- PrediFall / 2026-A00859-42
- Conditions
- Accidental Falls
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Slb PharmaUniversity, hospital or other
- Collaborators
- Université de Caen Normandie
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Predictive Performance of Baseline Biomarkers for Incident Falls
Time frame: From completion of baseline assessments through 12 months of prospective follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: 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.
Related trials for Accidental Falls
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Recruiting
Evaluation of the PPAL
Age Problems
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Accidental Falls, run by Slb Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Langeard, PhD (+332 31 56 82 24, antoine.langeard@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stable Candidate Multimodal Biomarkers Discriminating Participants With and Without Prior Falls (time frame: Baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.