Spatial and Ocular Trajectories for the Early Diagnosis of Alzheimer's Disease. (ACTSOMA)

January 24, 2024 updated by: Hospices Civils de Lyon

Joint Analysis of Spatial and Ocular Trajectories for the Early Diagnosis of Alzheimer's Disease.

Spatial navigation is a high-level cognitive function that enables humans to orientate themselves and move around in space by constructing a mental representation of the environment. It is particularly interesting because it involves numerous neural networks, linked to proprioception and vision, for example.

Despite the versatility of this cognitive function, spatial navigation is little studied clinically, although changes in spatial planning and navigation strategies have been associated with many brain disorders, including Alzheimer's disease (Coughlan et al., 2018). This may be explained in view of the neuropsychological tests currently in use, which do not effectively assess spatial navigation disorders. In addition, many non-pathological parameters - in particular socio-demographic and lifestyle - (Wolbers & Hegarty, 2010; Coutrot et al., 2018) affect spatial navigation performance. Separating the pathological component from these non-pathological factors in spatial navigation can be challenging.

In this context, Sea Hero Quest (SHQ) has been developed (Coutrot et al., 2018; Spiers et al., 2021) as an international-scale cognitive spatial navigation task that holds great promise for assessing spatial navigation performance during normal and pathological ageing. SHQ is a video game that implements classic tasks from the spatial cognition literature, and has enabled the trajectories of 4 million players with varied socio-demographic profiles to be collected.

In addition to the direct measurement of spatial displacements, eye movements, measured by eye-tracking, provide additional information on the cognitive processes associated with visual attention. The analysis of eye movements can provide valuable information about the strategies employed by humans during spatial navigation (Zhu et al., eLife 2023).

While it is well known that normal ageing and pathological ageing (e.g. in the context of Alzheimer's disease) affect performance in simple spatial navigation or visual attention tasks, the neurocognitive mechanisms involved in this deterioration remain poorly understood. The investigators hypothesise that the joint analysis of ocular and spatial traces will provide a more detailed understanding of the cognitive strategies deployed during a spatial navigation task, and therefore of these underlying mechanisms.

The investigators therefore propose to jointly study the association between two complementary cognitive functions: spatial navigation and visual attention, and their relationship with normal and pathological ageing (confirmed Alzheimer's disease, plasma biomarkers and genetic risk factors for Alzheimer's disease). The joint analysis of these different signals has never been carried out as part of research into normal ageing and Alzheimer's disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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

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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.
Interventional

Enrollment (Estimated)

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.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
      • Bron, France, 69500
        • Service de neuro-cognition et neuro-ophtalmologie Hôpital Pierre Wertheimer
        • Contact:
      • Pierre-Bénite, France, 69495
        • Service de médecine du vieillissement - Hôpital Lyon Sud
        • Contact:
    • Lyon
      • Villeurbanne, Lyon, France, 69100
        • Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Cognitively healthy subjects:

  • Participants aged between 20 and 85 years old;
  • Participant affiliated or entitled to a social security scheme;
  • Participants who have been informed and have given written consent.

Patients with Alzheimer's disease:

  • Participant aged between 50 to 85 years old;
  • Participant undergoing memory clinic consultations for a diagnosed Alzheimer's disease, at the stage of minor neurocognitive impairment or major neurocognitive impairment, according to the NIA-AA 2011 criteria (McKahn et al., 2011, Albert et al., 2011);
  • Mild to moderate cognitive impairment, Mini-Mental State Examination (MMSE ≥ 20/30, in the 6 months prior to inclusion);
  • Participant affiliated or entitled to a social security scheme;
  • Participants who have been informed and have given written consent.

Exclusion Criteria:

For all participants:

  • Severe, progressive or unstable pathology whose nature may interfere with the assessment variables (epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection);
  • Consumption of toxic substances that may affect cognitive performance;
  • Deafness or blindness that could compromise the participant's assessment or participation in tasks and scales;
  • Participants under guardianship or legal protection;
  • Pregnant women, women in labour or breastfeeding mothers;
  • Persons under psychiatric care.

Cognitively healthy subjects:

- Participants diagnosed with a cognitive disorder.

Specifically for patients with Alzheimer's disease:

  • Participants with a diagnosis other than Alzheimer's disease that promotes neurocognitive impairment (with the exception of cerebral microvascular involvement, i.e. mild to moderate microangiopathy);
  • Severe cerebral microangiopathy (extensive and severe white matter hypersignals, Fazekas score = 3);
  • Severe psycho-behavioral manifestations preventing performance of the task, at the investigator's discretion;
  • Current participation in an Alzheimer's disease drug research protocol, in particular testing 'disease-modifying' treatments that may interact with the pathophysiology of the disease (after randomisation).

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

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Active Comparator: Cognitively healthy subjects

Participants aged between 20 and 85 years old with no cognitive impairment (Montreal Cognitive Assessment ≥ 26/30 and MacNair Cognitive Difficulties Self-Rating Scale ≥15), affiliated or entitled to a social health insurance, having been informed and having given written consent to the study.

As part of the study, cognitively healthy subjects will :

  • Undergo a cognitive assessment;
  • Answer several questionnaires on their demographic data, lifestyle habits, quality of sleep, cognitive reserve, concomitant treatment and comorbidities;
  • Complete a cognitive spatial navigation task with eye-tracking;
  • Have a blood sampling for plasma biomarker and genetic risk factor for Alzheimer's disease.
Diagnostic test: Cognitive assessment

Group 1: Cognitively healthy subject:

After signing the consent form, during the only visit of the study, the investigator will administer to cognitively healthy subjects two cognitive screening tests to ensure that they meet the criteria for group 1. If performance on the cognitive scales prove to be borderline or below current standards (Montreal Cognitive Assessment ≥ 26/30 and MacNair Cognitive Difficulties Self-Rating Scale ≥15) for at least one of the 2 tests, the participant will prematurely end the study and may be offered an in-depth cognitive assessment as part of routine care.

Group 2: Patients suffering from Alzheimer's disease:

After signing the consent form, during the only visit of the study, the investigator will administer to patients the Montreal Cognitive Assessment to assess cognitive status.

Other: Questionnaires

For every participants (group 1 and 2):

During the only visit of the study and after the intervention 1, the participants will answer questionnaires about:

  • Demographic data such as age, gender, weight, height, education level;
  • Lifestyle habits such as usual mode of transport, sense of direction, use of GPS device, and video game practice;
  • Quality of sleep over the previous month and the previous night;
  • Cognitive reserve questionnaire from Rami et al., 2011;
  • Concomitant treatment and comorbidities.
Device: Spatial navigation task with eye-tracking.

For every participants (group 1 and 2):

During the only visit of the study and after interventions 1 and 2, the participants will complete the spatial navigation task with eye-tracking.

The participants will play the Sea Hero Quest video game and take on the role of the captain of a small boat that has to find its way through an aquatic environment. At the start of each level, the player is shown a map of the environment, with the boat's initial position and the buoys it must reach as quickly as possible in a set order. Once the map has been memorised, it disappears and the navigation begins.

Participants will play 6 levels of Sea Hero Quest (two training levels and four different navigation levels). This intervention will be proposed by a trained team member and participants will play on a digital tablet connected to an eye-tracker. The total duration of the task is 30 min (training phase + assessment sequences).

Biological: Blood sampling

For every participants (group 1 and 2):

During the only visit of the study and after interventions 1, 2 and 3, a state-qualified nurse will take venous samples from 3 tubes of 4ml each.

These blood samples will be frozen and stored until the end of the study when they will be analysed:

  • Sample 1: plasmatic Quanterix p-tau217 assay;
  • Sample 2: apolipoprotein E genotyping;
  • Sample 3: measurement of plasmatic creatinine levels. Neither the cognitively healthy subjects, nor the patients, nor the clinicians in charge of the patients included will be informed of the results of these biological assays (absence of clinical interest established at the present time of the APOE genotype and the p-tau217 protein level, absence of modification of the care pathway, in adequacy to the bioethics law of August 02, 2021. Creatinine level is used in this study as an adjustment variable to interpret the p-tau217 protein level and will not be used for clinical interpretation.
Experimental: Patients suffering from Alzheimer's disease

Patients aged between 50 and 85 years old, undergoing memory clinic consultation for prodromal or mild Alzheimer's disease with mild or moderate cognitive decline (Mini-Mental State Examination ≥20/30) affiliated or entitled to a social health insurance, having been informed and having given written consent to the study.

As part of the study, patients suffering from Alzheimer's disease will :

  • Undergo a cognitive assessment;
  • Answer several questionnaires on their demographic data, lifestyle habits, quality of sleep, cognitive reserve, concomitant treatment and comorbidities;
  • Complete a cognitive spatial navigation task with eye-tracking;
  • Have a blood sampling for plasma biomarker and genetic risk factor for Alzheimer's disease.
Diagnostic test: Cognitive assessment

Group 1: Cognitively healthy subject:

After signing the consent form, during the only visit of the study, the investigator will administer to cognitively healthy subjects two cognitive screening tests to ensure that they meet the criteria for group 1. If performance on the cognitive scales prove to be borderline or below current standards (Montreal Cognitive Assessment ≥ 26/30 and MacNair Cognitive Difficulties Self-Rating Scale ≥15) for at least one of the 2 tests, the participant will prematurely end the study and may be offered an in-depth cognitive assessment as part of routine care.

Group 2: Patients suffering from Alzheimer's disease:

After signing the consent form, during the only visit of the study, the investigator will administer to patients the Montreal Cognitive Assessment to assess cognitive status.

Other: Questionnaires

For every participants (group 1 and 2):

During the only visit of the study and after the intervention 1, the participants will answer questionnaires about:

  • Demographic data such as age, gender, weight, height, education level;
  • Lifestyle habits such as usual mode of transport, sense of direction, use of GPS device, and video game practice;
  • Quality of sleep over the previous month and the previous night;
  • Cognitive reserve questionnaire from Rami et al., 2011;
  • Concomitant treatment and comorbidities.
Device: Spatial navigation task with eye-tracking.

For every participants (group 1 and 2):

During the only visit of the study and after interventions 1 and 2, the participants will complete the spatial navigation task with eye-tracking.

The participants will play the Sea Hero Quest video game and take on the role of the captain of a small boat that has to find its way through an aquatic environment. At the start of each level, the player is shown a map of the environment, with the boat's initial position and the buoys it must reach as quickly as possible in a set order. Once the map has been memorised, it disappears and the navigation begins.

Participants will play 6 levels of Sea Hero Quest (two training levels and four different navigation levels). This intervention will be proposed by a trained team member and participants will play on a digital tablet connected to an eye-tracker. The total duration of the task is 30 min (training phase + assessment sequences).

Biological: Blood sampling

For every participants (group 1 and 2):

During the only visit of the study and after interventions 1, 2 and 3, a state-qualified nurse will take venous samples from 3 tubes of 4ml each.

These blood samples will be frozen and stored until the end of the study when they will be analysed:

  • Sample 1: plasmatic Quanterix p-tau217 assay;
  • Sample 2: apolipoprotein E genotyping;
  • Sample 3: measurement of plasmatic creatinine levels. Neither the cognitively healthy subjects, nor the patients, nor the clinicians in charge of the patients included will be informed of the results of these biological assays (absence of clinical interest established at the present time of the APOE genotype and the p-tau217 protein level, absence of modification of the care pathway, in adequacy to the bioethics law of August 02, 2021. Creatinine level is used in this study as an adjustment variable to interpret the p-tau217 protein level and will not be used for clinical interpretation.

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
Analysis of spatial navigation strategies used by participants according to age.
Time Frame: Day 1 Just After inclusion

Spatial navigation strategies will be described thanks to machine learning identifying spatial navigation patterns taking into consideration:

  • Spatial performances: length of trajectories sampled at 2Hz (1 x-y coordinate every 500 ms) - the shorter the trajectory, the better the performance;
  • Eye movements: gaze sampling recorded and sampled at 60Hz to identify visual clues used by participants to solve the spatial task).

These patterns will be described according to participant's age.
Day 1 Just After inclusion

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
Cognitive health status: presence or absence of diagnosed Alzheimer's disease.
Time Frame: Day 1 Just After inclusion
Spatial navigation strategies will be compared according to participant's cognitive status (cognitively healthy versus Alzheimer's disease).
Day 1 Just After inclusion
P-tau217 plasmatic protein assay in pg/mL interpreted in relation to creatinine levels and body mass index.
Time Frame: Day 1 Just After inclusion
Spatial navigation strategies will be compared according to the p-tau217 plasmatic protein assay. A Simoa (Single Molecule Array for Protein Detection) platform will use commercial kits to carry out the p-tau217 protein assay (Quanterix).
Day 1 Just After inclusion
Genotyping of the apolipoprotein E gene: ApoE4 carrier or ApoE4 non carrier.
Time Frame: Day 1 Just After inclusion
Spatial navigation strategies will be compared according to the genotyping. A molecular biology platform will carry out genotyping for apolipoprotein E
Day 1 Just After inclusion

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.
Hospices Civils de Lyon

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: Antoine GARNIER-CRUSSARD, HCL

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 (Estimated)

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.
March 1, 2024

Primary Completion (Estimated)

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.
September 1, 2025

Study Completion (Estimated)

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.
September 1, 2025

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).
January 10, 2024

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.
January 10, 2024

First Posted (Actual)

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.
January 19, 2024

Study Record Updates

Last Update Posted (Actual)

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.
January 26, 2024

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.
January 24, 2024

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.
January 1, 2024

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.
  • 69HCL23_1166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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