Aging Clinical Trial
— PrediCogOfficial title:
Cerebral MRI Markers and Oculomotor Indices in Human Ageing: Potential Predictors of Cognitive Maintenance or Decline
This research proposes to investigate physiological and cognitive markers of locus coeruleus (LC) neuronal integrity and function in cognitively-healthy participants over 60 years old. The locus coeruleus is a brainstem nucleus, sole source of noradrenaline for the brain. Tau pathology appears in neurons of this nucleus, which may induce initial cognitive changes. The study aims at relating locus coeruleus markers, assessed with MRI and eye-tracking techniques, with cognitive function.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2026 |
Est. primary completion date | July 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 100 Years |
Eligibility | Inclusion Criteria: - INSPIRE cohort participant - Mini-Mental State Examination score = 27 on 30 - Access to a web connection from participant's or relative's home and regular use of web surfing - Signature of the informed consent - Affiliated to a social security scheme Exclusion Criteria: - Any contra-indications to MRI exam - Ophthalmic pathology impacting eye-tracking measures - Neurological or psychiatric pathology - Person under guardianship or curatorship Contraindications to MRI examination: - Pacemaker or cardiac defibrillator - Implanted material activated by an electrical, magnetic or mechanical system - Haemostatic clips for intracerebral aneurysms or carotid arteries - Orthopedic implants - Claustrophobia Ophthalmological pathologies impacting eye tracking measurements: - Glaucoma - Age-related macular degeneration - Unoperated cataract |
Country | Name | City | State |
---|---|---|---|
France | University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Imaging contrast between the LC nucleus and the pontine tegmentum region | The outcome will be measured with brainstem anatomical MRI (no unit) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion). | 18 months | |
Secondary | Z-score of the LC-forebrain connectivity at rest | It will be assessed with resting-state functional MRI (no unit) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion). | 18 months | |
Secondary | Amplitude of the phasic pupil response during completion of cognitive tasks | It will be assessed with eye-tracking (in millimeter) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion). | 18 months | |
Secondary | Latency of saccadic eye movements during completion of cognitive tasks | It will be assessed with eye-tracking (in milliseconds) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion). | 18 months | |
Secondary | Amplitude of saccadic eye movements during completion of cognitive tasks | It will be assessed with eye-tracking (in millimeter) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion). | 18 months | |
Secondary | Composite cognitive (executive and memory) score | It will be assessed (no unit) at visits V1 (immediately after inclusion), V2 (6 months after inclusion), V3 (12 months after inclusion) and V4 (18 months after inclusion). | 18 months | |
Secondary | Levels of blood phospho-Tau | It will be assessed by single-molecule array (Simoa) technology (picogram/ml) | 18 months |
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