Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease (NCT05911178) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease
France90 participantsStarted 2023-10-18
Plain-language summary
This study aims to analyse, in vivo, the interplay between microglial activation and tau pathology in Alzheimer's disease (AD) using \[18F\]-DPA-714 and \[18F\]-Ro948 tracers by Position Emission Tomography (PET), and their consequences on synaptic density using \[11C\]-UCB-J, a recent PET radioligand.
By coupling advanced neuroimaging techniques in AD patients, while comparing them to controls, we will be able to study, for the first time in humans, the interaction between neuroinflammation, tau pathology, synaptic density, and their impact on AD progression. Joint analyses of peripheral immune biomarkers, carried out as a secondary objective, will further aim at defining peripheral correlates of this interplay.
Overall, we aim to refine AD subgroup classification in order to improve and to refine the design of new therapeutic trials.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in regional microglial activation and tau pathology from baseline at 24 months
Timeframe: 24 months
2
Change in regional synaptic density from baseline at 24 months