NCT05273125 MOBility Disorders Assessment in Patients With Mild COGnitive Disorders
| NCT ID | NCT05273125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Cognitive Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 417 participants |
| Start Date | 2022-09-09 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 417 participants in total. It began in 2022-09-09 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI. The research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location. We aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.
Eligibility Criteria
Inclusion Criteria: * Patient being diagnosed with MCI, according to the 2011 criteria * Able to walk 4 meters with or without technical assistance * Comprehension of French language allowing the realization of the neuropsychological assessment Exclusion Criteria: * Severe visual or hearing impairment that does not allow the assessment * Severe pathology that makes follow-up impossible * Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security insurance, refusal to sign consent form * Under legal protection (guardianship, curatorship, safeguard of justice)
Contact & Investigator
Yaohua CHEN, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT05273125 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05273125 currently recruiting?
Yes, NCT05273125 is actively recruiting participants. Contact the research team at Yaohua.chen@chru-lille.fr for enrollment information.
Where is the NCT05273125 trial being conducted?
This trial is being conducted at Lille, France, Lille, France.
Who is sponsoring the NCT05273125 clinical trial?
NCT05273125 is sponsored by University Hospital, Lille. The principal investigator is Yaohua CHEN, MD at University Hospital, Lille. The trial plans to enroll 417 participants.