Pre-demential Motoric Cognitive Risk Syndrome in Ageing Subjects

NCT05640141 | Unknown DMC

• 1 other identifier: PRESAGE
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the study is to characterize and understand the pathological mechanisms underlying the motoric cognitive risk syndrome, which is a predictor of Alzheimer disease.

Conditions

Motoric Cognitive Risk Syndrome; Mild Cognitive Impairment; Alzheimer Disease; Dementia

Keywords

MRI; Cognition; Gait; Executive functions; Virtual reality; Motion capture

Outcome Measures

Primary Outcomes (1)

• Prediction accuracy to detect MCR participants will be computed using Machine learning

  Several machine learning algorithms will be used to tell apart healthy from MCR participants. These classification procedures will bring several metrics including prediction accuracy, sensitivity and specificity scores.

  Baseline

Secondary Outcomes (4)

• MRI - Brain volumes

  Baseline

• MRI - Connectivity

  Baseline

• Gait - Dual task cost

  Baseline

• Gait - Sensorimotor adaptation and savings

  Baseline

Study Arms (2)

Control

Control group composed of 80 healthy aged volunteers.

Procedure: MRI evaluation; Behavioral: Actimetry & IMU; Behavioral: Gait evaluation; Behavioral: Neuropsychological evaluation

Motoric Cognitive Syndrom

MCR group composed of 80 MCR participants.

Procedure: MRI evaluation; Behavioral: Actimetry & IMU; Behavioral: Gait evaluation; Behavioral: Neuropsychological evaluation

Interventions

MRI evaluation PROCEDURE

Multimodal MRI evaluation : * T1 structural, * Resting echo planar imaging * Diffusion-weighted imaging * Arterial sping labeling * Fluid-attenuated inversion recovery

Control; Motoric Cognitive Syndrom

Actimetry & IMU BEHAVIORAL

Evaluation of daily activities and life rythms (physical activity, inactivity, sleep) using actimeters (Motion 8), inertial sensors (GaitUP) and questionaires during 14 days : * Actimetry : evaluation of daily activity and inactivity, sleep rythms * Inertial sensors : gait evaluation during daily activities * Questionaires : sleep (Spiegel \& St Mary's Hospitral) and fatigue (MFI-20)

Control; Motoric Cognitive Syndrom

Gait evaluation BEHAVIORAL

Evaluation of gait characteristics (spatio-temporal parameters \& non-linear characteristics) in virtual environment : * Locomotor simple task : gait only in congruent environment * Locomotor dual task : gait in similar environment combined with a visually displayed Stroop task * Sensorimotor gait adaptaition : evaluation of the adaptation capability throughout a split-belt treadmill sequence (realized in simple or dual -combined with the visual Stroop task-)

Control; Motoric Cognitive Syndrom

Neuropsychological evaluation BEHAVIORAL

Complete neuropsychological examination including attentional and executive functions, learning and retrieval abilities in episodic memory and general cognitive skills : * Divided attention (TAP; test of attentional performance) * California Verbal Learning Test * The Rey-Osterrieth Complex Figure * Symbol search and coding (WAIS-IV) * Go/No-go (TAP) * Flexibility (TAP) * Original task of multimodal integration * Verbal fluencies (GREFEX)

Control; Motoric Cognitive Syndrom

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Controls : health volunteers without any reduced gait speed or cognitive complaint MCR : reduced gait speed, cognitive complaint Both : normal cognitive function

You may qualify if:

• Aged 55-75 years
• Right-handed as assessed by the Edinburgh Inventory
• Health Insurance
• Able to follow experimental instructions
• Consent
• Independent in daily life activities as assessed by Katz autonomy score, ADL and IADL
• Reduced gait speed as assessed by the 4m or 10m walk test value compared to normative values (Bohannon \& Williams Andrews, 2011)
• Subjective cognitive complaint as assessed by dedicated questionnaire
• Subnormal cognitive function as assessed by the Montreal Cognitive Assessment (MoCA) test with score \> 23
• \- Subnormal cognitive function as assessed by the Montreal Cognitive Assessment (MoCA) test with score \> 23

You may not qualify if:

• Uncorrected visual or auditive deficits not allowing the realization of the experiment
• Evolutive disease (such as cancer)
• Active depression
• Neurological or psychiatric antecedent
• Neuromuscular impairment
• BMI \< 35
• Counter-indication to MRI

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen Normandie

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia

Interventions

24,25-oxidolanosterol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Pierre Denise, MD, PhD

  CHU de Caen Normandie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie M. Decker, PhD

CONTACT

06.70.40.58.44; leslie.decker@unicaen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: January 26, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: December 7, 2022

Record last verified: 2021-12

Locations

FR (1)