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

View full record on ClinicalTrials.gov

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