MOBility Disorders Assessment in Patients With Mild COGnitive Disorders

Cognitive Dysfunction Clinical Trial

— COG-MOB  

Official title:

Multimodal and Longitudinal Assessment of MOBility Disorders in Patients With Mild COGnitive Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05273125
• Other study ID #: 2020_55
• Secondary ID: 2021-A00637-34
• Status: Recruiting
• Start date: September 9, 2022
• Est. completion date: September 2025

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Yaohua CHEN, MD
• Phone: 0320445962
• Email: Yaohua.chen[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 417
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction

Intervention

Behavioral:
• Gait disorders and falls risk assessment
Implementation of a standardized assessment of the fall risk and gait disorders in the memory clinic in addition to usual care.

Locations

Country	Name	City	State
France	Hop Salengro - Hopital B	Lille
France	Les Bateliers Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existence of at least one fall	The primary objective is to identify factors predictive of having at least one fall at one year First, the relationship between each candidate risk factor (independent variables) and the presence of at least one fall at one year (binary dependent variable) will be studied by bivariate logistic regression models. For quantitative candidate factors, the log-linearity assumption of the logistic regression model will be tested using cubic spline functions, which models the non-linear effect. The 10 pre-selected factors will be included in a multivariate logistic regression model, regardless of the outcome of the bi-variate analyses. The multivariate analysis will be performed following the recommendations of Peduzzi et al on the number of variables to include in a multivariate model (10 events per estimated parameter).	12 months
Secondary	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		6 months and 12 months
Secondary	Patients enrollment rate	Adherence and acceptability of the multimodal assessment in the memory clinic	12 months
Secondary	Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)	Adherence and acceptability of the multimodal assessment in the memory clinic	12 months
Secondary	Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers		12 months
Secondary	Rate of serious falls allowing the comparison of the same variables in the subgroup of patients who had had at least one serious fall		12 months
Secondary	Timeframe until conversion to major cognitive impairment according to the criteria of NIA-AA of 2011		12 months