Motoric Cognitive Risk SyndromePRESAGENCT05640141
Pre-demential Motoric Cognitive Risk Syndrome in Ageing Subjects
An observational study of Motoric Cognitive Risk Syndrome and Mild Cognitive Impairment, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motoric Cognitive Risk Syndrome, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- MRI evaluation, Actimetry & IMU and Gait evaluation
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Controls : health volunteers without any reduced gait speed or cognitive complaint MCR : reduced gait speed, cognitive complaint Both : normal cognitive function
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen Normandie
Caen, 14000
Pierre Denise, MD, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- MRI evaluation, Actimetry & IMU, Gait evaluation, Neuropsychological evaluation
- Keywords
- MRI, Cognition, Gait, Executive functions, Virtual reality, Motion capture
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI evaluationProcedure or surgery
Multimodal MRI evaluation :
- T1 structural,
- Resting echo planar imaging
- Diffusion-weighted imaging
- Arterial sping labeling
- Fluid-attenuated inversion recovery
Actimetry & IMUBehavioural
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)
Gait evaluationBehavioural
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-)
Neuropsychological evaluationBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Control | Control group composed of 80 healthy aged volunteers. Receives: Procedure: MRI evaluation; Behavioral: Actimetry & IMU; Behavioral: Gait evaluation; Behavioral: Neuropsychological evaluation | |
| Motoric Cognitive Syndrom | MCR group composed of 80 MCR participants. Receives: Procedure: MRI evaluation; Behavioral: Actimetry & IMU; Behavioral: Gait evaluation; Behavioral: Neuropsychological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
MRI - Brain volumes
Grey and white matter atrophy, grey matter structural covariation and white matter hyperintensity will be assessed.
Measured: Baseline
MRI - Connectivity
Brain connectivity (covariation patterns) in each group will be computed.
Measured: Baseline
Gait - Dual task cost
Difference in spatio-temporal and non-linear gait parameters bewteen simple and dual task / between groups
Measured: Baseline
Gait - Sensorimotor adaptation and savings
Difference in terms of sensorimotor adaptation on split-belt treadmill bewteen groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start26 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motoric Cognitive Risk SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Denise, MD, PhD, Principal investigator, CHU de Caen Normandie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640141
- Sponsor's protocol ID
- PRESAGE
- Acronym
- PRESAGE
- Status last verified
- Dec 2021
- First submitted
- 28 Nov 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-demential Motoric Cognitive Risk Syndrome in Ageing Subjects - Prediction of Cognitive Decline and Identification of Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT05640141
- Acronym / sponsor ID
- PRESAGE / PRESAGE
- Keywords
- MRI, Cognition, Gait, Executive functions, Virtual reality, Motion capture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: MRI evaluation, Behavioral: Actimetry & IMU, Behavioral: Gait evaluation, Behavioral: Neuropsychological evaluationControl group composed of 80 healthy aged volunteers. |
| Motoric Cognitive Syndrom | – | Procedure: MRI evaluation, Behavioral: Actimetry & IMU, Behavioral: Gait evaluation, Behavioral: Neuropsychological evaluationMCR group composed of 80 MCR participants. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Controls : health volunteers without any reduced gait speed or cognitive complaint MCR : reduced gait speed, cognitive complaint Both : normal cognitive function
Key inclusion criteria (10 listed)
- Aged 55-75 years
- Right-handed as assessed by the Edinburgh Inventory
- Health Insurance
- Able to follow experimental instructions
- Consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI evaluationMultimodal MRI evaluation : * T1 structural, * Resting echo planar imaging * Diffusion-weighted imaging * Arterial sping labeling * Fluid-attenuated inversion recovery | Procedure or surgery | Control, Motoric Cognitive Syndrom |
| Actimetry & IMUEvaluation 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) | Behavioural | Control, Motoric Cognitive Syndrom |
| Gait evaluationEvaluation 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-) | Behavioural | Control, Motoric Cognitive Syndrom |
| Neuropsychological evaluationComplete 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) | Behavioural | Control, Motoric Cognitive Syndrom |
Primary outcome
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.
4 secondary outcomes
MRI - Brain volumes
Time frame: Baseline
MRI - Connectivity
Time frame: Baseline
Gait - Dual task cost
Time frame: Baseline
Gait - Sensorimotor adaptation and savings
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Denise, MD, PhD principal investigator
CHU de Caen Normandie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motoric Cognitive Risk Syndrome and Mild Cognitive Impairment, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leslie M. Decker, PhD (06.70.40.58.44 ext. +33, leslie.decker@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction accuracy to detect MCR participants will be computed using Machine learning (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.