Alzheimer DiseaseACTSOMANCT06213766
Spatial and Ocular Trajectories for the Early Diagnosis of Alzheimer's Disease.
A study testing Cognitive assessment, Questionnaires and Spatial navigation task with eye-tracking. in people with Alzheimer Disease and Aging, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Aging
- What is being tested?
- Cognitive assessment, Questionnaires and Spatial navigation task with eye-tracking.
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2024to 1 Sep 2025
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 14Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de neuro-cognition et neuro-ophtalmologie Hôpital Pierre Wertheimer
Bron, 69500
Maïté FORMAGLIO, MD, 04 72 11 80 71 ext. +33, maite.formaglio@chu-lyon.fr
Service de médecine du vieillissement - Hôpital Lyon Sud
Pierre-Bénite, 69495
Claire SCHUTZ, Dr, 04 78 86 39 40, claire.schutz@chu-lyon.fr
Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon
Villeurbanne, Lyon, 69100
About this study
Official title: 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.
Read more
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.
- Conditions
- Alzheimer Disease, Aging
- Being tested
- Cognitive assessment, Questionnaires, Spatial navigation task with eye-tracking., Blood sampling
- Keywords
- Alzheimer Disease, spatial navigation, eye-tracking, biomarkers, early diagnosis, personalized medicine, machine learning
- Medical subject headings
- Alzheimer Disease, Spatial Navigation, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive assessmentDiagnostic test
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.
QuestionnairesOther
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.
Spatial navigation task with eye-tracking.Device
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).
Blood samplingBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively healthy subjects | Active comparator | 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. Receives: Diagnostic Test: Cognitive assessment; Other: Questionnaires; Device: Spatial navigation task with eye-tracking.; Biological: Blood sampling |
| Patients suffering from Alzheimer's disease | Experimental | 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. Receives: Diagnostic Test: Cognitive assessment; Other: Questionnaires; Device: Spatial navigation task with eye-tracking.; Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of spatial navigation strategies used by participants according to age.
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.
Measured: Day 1 Just After inclusion
Secondary outcomes (3)
Cognitive health status: presence or absence of diagnosed Alzheimer's disease.
Spatial navigation strategies will be compared according to participant's cognitive status (cognitively healthy versus Alzheimer's disease).
Measured: Day 1 Just After inclusion
P-tau217 plasmatic protein assay in pg/mL interpreted in relation to creatinine levels and body mass index.
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).
Measured: Day 1 Just After inclusion
Genotyping of the apolipoprotein E gene: ApoE4 carrier or ApoE4 non carrier.
Spatial navigation strategies will be compared according to the genotyping. A molecular biology platform will carry out genotyping for apolipoprotein E
Measured: Day 1 Just After inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine GARNIER-CRUSSARD, Principal investigator, HCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213766
- Sponsor's protocol ID
- 69HCL23_1166
- Acronym
- ACTSOMA
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Analysis of Spatial and Ocular Trajectories for the Early Diagnosis of Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT06213766
- Acronym / sponsor ID
- ACTSOMA / 69HCL23_1166
- Conditions
- Alzheimer Disease, Aging
- Keywords
- Alzheimer Disease, spatial navigation, eye-tracking, biomarkers, early diagnosis, personalized medicine, machine learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Jan 2024 (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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitively healthy subjects | Active comparator | Diagnostic Test: Cognitive assessment, Other: Questionnaires, Device: Spatial navigation task with eye-tracking., Biological: Blood samplingParticipants 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. |
| Patients suffering from Alzheimer's disease | Experimental | Diagnostic Test: Cognitive assessment, Other: Questionnaires, Device: Spatial navigation task with eye-tracking., Biological: Blood samplingPatients 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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);
Key exclusion criteria (14 listed)
- 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;
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 |
|---|---|---|
| Cognitive assessmentGroup 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. | Diagnostic test | Cognitively healthy subjects, Patients suffering from Alzheimer's disease |
| QuestionnairesFor 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. | Other | Cognitively healthy subjects, Patients suffering from Alzheimer's disease |
| 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). | Device | Cognitively healthy subjects, Patients suffering from Alzheimer's disease |
| Blood samplingFor 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. | Biological | Cognitively healthy subjects, Patients suffering from Alzheimer's disease |
Primary outcome
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.
3 secondary outcomes
Cognitive health status: presence or absence of diagnosed Alzheimer's disease.
Time frame: 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
Genotyping of the apolipoprotein E gene: ApoE4 carrier or ApoE4 non carrier.
Time frame: Day 1 Just After inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Antoine GARNIER-CRUSSARD principal investigator
HCL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive assessment, Questionnaires and Spatial navigation task with eye-tracking. in people with Alzheimer Disease and Aging, run by Hospices Civils de Lyon at 3 sites 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 14 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Antoine GARNIER-CRUSSARD, Dr (04 72 43 20 50, antoine.garnier-crussard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of spatial navigation strategies used by participants according to age. (time frame: Day 1 Just After inclusion). 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 26 Jan 2024.