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Impact of microglial activation on synaptic density in Alzheimer’s disease
EU CTIS ID: 2024-516566-11-00
What this study is testing
Analyze, in vivo, the interplay between microglial activation and tau pathology in Alzheimer disease (AD) using respectively [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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- General inclusion criteria: Adult (men or women), Women old enough to procreate under effective contraception, signed consent, for the patients absence of general or systemic disorders that may interfere with cognition.
- IFor the 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.
- For patients with Alzheimer’s Disease at the early stage: AD patients will be defined as EOAD or LOAD according to the age of the onset of the disease as EOAD: onset of the disease ≤ 65 years and LOAD: onset of the disease > 65 years.
- Progressive amnestic syndrome, associated or not with other cognitive impairments or predominant parietal cognitive, CDR = 0.5 or 1 syndrome (parietal phenotype of AD) for EOAD,
- 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.
You likely can't join if
- Subject with a psychiatric evolutionary and/or badly 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.
See the full eligibility criteria
- General inclusion criteria: Adult (men or women), Women old enough to procreate under effective contraception, signed consent, for the patients absence of general or systemic disorders that may interfere with cognition.
- IFor the 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.
- For patients with Alzheimer’s Disease at the early stage: AD patients will be defined as EOAD or LOAD according to the age of the onset of the disease as EOAD: onset of the disease ≤ 65 years and LOAD: onset of the disease > 65 years.
- Progressive amnestic syndrome, associated or not with other cognitive impairments or predominant parietal cognitive, CDR = 0.5 or 1 syndrome (parietal phenotype of AD) for EOAD,
- 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
- Subject with a psychiatric evolutionary and/or badly 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 study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.