Biomarkers of the Locus Coeruleus Nucleus: Links With Early Tau Pathology, Cognition and Alzheimer's Disease Risk
Recruiting · NCT07007208 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →Interventions studied
MRI Contrasta positon emission tomography (PET) examcognitive examsoculometry assessment
What this trial is about
Alzheimer's disease (AD) is characterized by a long-lasting silent phase. Among initial events, emergence of tau pathology in locus coeruleus (LC) brainstem nucleus, well before the one observed in medial temporal cortex, is highly relevant. LC integrity and function can be assessed in vivo with MRI and pupil measures. The current research proposes to evaluate these LC markers in an aged healthy cohort (n=100, with half APOE4 positive) and to relate these markers with cerebral tau pathology, AD risk and cognitive function.
Who can take part
Age range
60 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participant in the INSPIRE-T cohort
- Normal cognitive assessment
- MMSE score ≥ 27 out of 30 (Mini-Mental State Examination)
- Normal visual abilities (in corrected or uncorrected vision)
- Normal motor skills
Exclusion criteria
- Subjects with a contraindication to MRI exam
- Subjects with a known allergic reaction to the PET radiopharmaceutical (\[18F\] Flortaucipir) or any of its excipients
- Subjects with an ophthalmological pathology making oculometric measurements difficult
- Subjects with a neurodegenerative condition or a history of cerebral ischemia
- Subjects with a psychiatric disorder and a PHQ-9 score \> 10 or under treatment with NRI
Where it is running
1 location listed.
- University Hospital of Toulouse - Toulouse, France