Pre-demential Motoric Cognitive Risk Syndrome in Ageing Subjects (PRESAGE)

November 28, 2022 updated by: University Hospital, Caen

Pre-demential Motoric Cognitive Risk Syndrome in Ageing Subjects - Prediction of Cognitive Decline and Identification of Underlying Mechanisms

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alzheimer's disease (AD) is affecting more than 46.8 million people worldwide, making dementia one of the greatest public health challenges of the 21st century. The progression of AD is slow with a presymptomatic course over several years to decades, during which pathophysiological changes are underway, but the disease has not yet caused any noticeable symptoms to warrant a clinical diagnosis. A strong effort is ongoing to identify biomarkers preceding cognitive decline that can aid diagnosis and early intervention. Criteria for the motoric cognitive risk syndrome (MCR), including subjective cognitive decline (SCD) and slower preferred walking speed, but otherwise normal functioning, are powerful risk indicators of developing cognitive impairment and dementia. The presence of MCR is associated with a more than three-fold risk of developing dementia while the risk is only two-fold for SCD or slow gait alone. However, the pathophysiology of MCR is unknown and getting into the processes that cause such condition is needed to complement the MCR-based criteria and increase their predictive validity of cognitive decline and dementia. Impaired attentional control related to white matter alterations of presumed vascular origin may be responsible for the MCR phenotype. Individuals with SCD exhibit loss of white matter integrity in brain regions typically involved in attentional control, and abnormally slow gait has been linked to the disruption of white matter tracts associated with executive attention. Furthermore, a deeper understanding of MCR requires considering not only regional white matter changes but also the individuals' cognitive capacity to cope with brain damages, namely the cognitive reserve. Hence, the PRESAGE project intends to evaluate the interplay of white matter integrity and cognitive reserve on attentional control in MCR and non-MCR individuals aged 60 or older. Attentional control will be explored at both the behavioral and brain levels using dual-task challenges where individuals will have to divide attention between a cognitive (stroop) task and a motor task (walking). The working hypothesis is that the dual-task cost - a proxy of attentional control - is predictive of white matter abnormalities which, when adjusted for cognitive reserve, age and sex, should discriminate between MCR and non-MCR individuals. The project also includes a prospective, longitudinal study (two-year follow-up) whose purpose is to determine whether this marker, alone or in combination with other potentially relevant markers (i.e., neuropsychological, functional and chronobiological), have predictive value for conversion from MCR to mild cognitive impairment and dementia. Findings will increase knowledge about the pathophysiology of MCR and will contribute to improve MCR criteria and early identification of at-risk individuals.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • CHU de Caen Normandie
        • Contact:
          • Pierre Denise, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion criteria:

  • 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

Inclusion criteria (MCR group specific)

  • 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

Inclusion criteria (Controls group specific)

- Subnormal cognitive function as assessed by the Montreal Cognitive Assessment (MoCA) test with score > 23

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Control
Control group composed of 80 healthy aged volunteers.
Procedure: MRI evaluation

Multimodal MRI evaluation :

  • T1 structural,
  • Resting echo planar imaging
  • Diffusion-weighted imaging
  • Arterial sping labeling
  • Fluid-attenuated inversion recovery
Behavioral: Actimetry & IMU

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)
Behavioral: Gait evaluation

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-)
Behavioral: Neuropsychological evaluation

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)
Motoric Cognitive Syndrom
MCR group composed of 80 MCR participants.
Procedure: MRI evaluation

Multimodal MRI evaluation :

  • T1 structural,
  • Resting echo planar imaging
  • Diffusion-weighted imaging
  • Arterial sping labeling
  • Fluid-attenuated inversion recovery
Behavioral: Actimetry & IMU

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)
Behavioral: Gait evaluation

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-)
Behavioral: Neuropsychological evaluation

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prediction accuracy to detect MCR participants will be computed using Machine learning
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MRI - Brain volumes
Time Frame: Baseline
Grey and white matter atrophy, grey matter structural covariation and white matter hyperintensity will be assessed.
Baseline
MRI - Connectivity
Time Frame: Baseline
Brain connectivity (covariation patterns) in each group will be computed.
Baseline
Gait - Dual task cost
Time Frame: Baseline
Difference in spatio-temporal and non-linear gait parameters bewteen simple and dual task / between groups
Baseline
Gait - Sensorimotor adaptation and savings
Time Frame: Baseline
Difference in terms of sensorimotor adaptation on split-belt treadmill bewteen groups
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Caen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Denise, MD, PhD, CHU de Caen Normandie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRESAGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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