Examining how microglial activation affects synaptic density in Alzheimer's disease
Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease
NA · Centre Hospitalier St Anne · NCT05911178
This study is trying to see how brain inflammation affects connections between brain cells in people with Alzheimer's disease compared to healthy individuals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne (other) |
| Locations | 3 sites (Lille and 2 other locations) |
| Trial ID | NCT05911178 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between microglial activation, tau pathology, and synaptic density in Alzheimer's disease using advanced PET imaging techniques. By comparing Alzheimer's patients with healthy controls, the study aims to understand how neuroinflammation impacts disease progression. It employs multiple PET radioligands and MRI to analyze these interactions over a two-year period, with a focus on refining subgroup classifications for better therapeutic trial designs. Additionally, peripheral immune biomarkers will be assessed to identify correlates of neuroinflammation.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a progressive amnestic syndrome and specific CSF biomarker profiles suggestive of Alzheimer's disease.
Not a fit: Patients with significant systemic disorders affecting cognition or those without Alzheimer's disease symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and classification of Alzheimer's disease, potentially guiding more effective treatments.
How similar studies have performed: Other studies have shown promise in using neuroimaging to explore neuroinflammation in Alzheimer's, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lille and 2 other locations
- CHU de Lille — Lille, France (NOT_YET_RECRUITING)
- GHU Saint Anne Psychiatrie & Neurosciences — Paris, France (RECRUITING)
- CHU de Rouen — Rouen, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Marie SARAZIN, MD, Prof — GHU Sainte-Anne
- Study coordinator: Khaoussou SYLLA, MD, PhD
- Email: k.sylla@ghu-paris.fr
- Phone: 01.45.65.76.78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease, Neuroinflammation, Microglial activation, Synaptic density, Tau pathology, Peripheral immunity