Clinical trial NCT05273125: MOBility Disorders Assessment in Patients With Mild COGnitive Disorders
Official title: Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Dysfunction
Keywords: Mild Cognitive Impairement
Falls
Predictive factors
Elderly
Gait disorders assessment.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 417
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients with MCI followed in memory centers

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)

Primary outcomes:
measure: Existence of at least one fall
timeFrame: 12 months
Secondary outcomes:
measure: Comparison between the fall schedule given and kept by the patient and / or his main caregiver and the collection of anamnestic data on the occurrence of falls
timeFrame: 6 months and 12 months
measure: Patients enrollment rate
timeFrame: 12 months
measure: Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)
timeFrame: 12 months
measure: Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers
timeFrame: 12 months
measure: Rate of serious falls allowing the comparison of the same variables in the subgroup of patients who had had at least one serious fall
timeFrame: 12 months
measure: Timeframe until conversion to major cognitive impairment according to the criteria of NIA-AA of 2011
timeFrame: 12 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Les Bateliers Chu Lille
city: Lille
country: France
facility: Hop Salengro - Hopital B
Study officials:
affiliation: University Hospital, Lille
name: Yaohua CHEN, MD
role: PRINCIPAL_INVESTIGATOR
References: