NCT06213766 · UNKNOWN
Spatial and Ocular Trajectories for the Early Diagnosis of Alzheimer's Disease.
This study is testing whether tracking how people navigate through a video game environment — combined with eye-movement data — can help detect Alzheimer's disease earlier. Researchers will compare spatial navigation patterns and eye tracking between healthy adults and people already diagnosed with Alzheimer's. It is a diagnostic study, not a drug trial, meaning no treatment is given and researchers are evaluating a potential early detection tool, not a therapy.
Eligibility criteria
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).
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-01-26