Status:
NOT_YET_RECRUITING
Spatial and Ocular Trajectories for the Early Diagnosis of Alzheimer's Disease.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Alzheimer Disease
Aging
Eligibility:
All Genders
20-85 years
Phase:
NA
Brief 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 particularl...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06213766
Start Date
March 1 2024
End Date
September 1 2025
Last Update
January 26 2024
Active Locations (3)
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1
Hôpital des Charpennes, Institut du Vieillissement, Hospices Civils de Lyon
Villeurbanne, Lyon, France, 69100
2
Service de neuro-cognition et neuro-ophtalmologie Hôpital Pierre Wertheimer
Bron, France, 69500
3
Service de médecine du vieillissement - Hôpital Lyon Sud
Pierre-Bénite, France, 69495