NCT05911178 · RECRUITING
Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease
This observational study uses four PET brain scans to map, at the same time, brain inflammation, tau protein tangles, amyloid plaques, and synapse loss in people with Alzheimer's disease versus healthy controls. No drug or treatment is given. Phase NA means this is a research imaging study, not a drug trial — it is designed to understand disease biology and help design better future trials.
Eligibility criteria
Inclusion Criteria: General Inclusion Criteria: * Adult (older than 18 years) * Women old enough to procreate under effective contraception * Signed consent * Absence of general or systemic disorders that may interfere with cognition. Inclusion criteria for EOAD and LOAD patients: * Progressive amnestic syndrome, associated or not with other cognitive impairments, * CDR = 0.5 or 1 * Absence of general or systemic disorders that may interfere with cognition or PET imaging analysis, * Absence of brain lesions as determined by MRI carried out within the framework of usual care. * Presence of CSF biomarkers profile suggestive of AD Inclusion criteria for controls: * absence of subjective problems with memory and normal scores on the MMSE (MMSE > 27) with no more than one word missing. * older than 50 years old. * Scores on the Free and Cued Selective Reminding Test (FCSRT) of >25 for free recall and >44 for total recall. * absence of general or systemic disorders that may interfere with cognition at follow-up. Controls will be matched to AD patients for age and education level. Exclusion Criteria: * Subject with a psychiatric evolutionary and/or poorly checked pathology (left to the judgement of the investigator). * Subject with a grave, severe or unstable pathology (left to the judgement of the investigator) the nature of which can interfere with the variables of evaluation. * Current auto-immune disease * Subject presenting contraindications to the 3T MRI * Known or supposed histories (≤5 years) of severe alcoholism or misuse of drugs * Vascular, inflammatory or expansive, visible lesion in the MRI which can interfere on the criteria of diagnosis. * No health insurance * Pregnant, breast-feeding woman or planning a pregnancy in two years of follow-up. * Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders. * Person placed under the protection of justice * Patient under guardianship or curatorship
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 2024-06-13