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NCT05911178Active, not recruiting

Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease

Source: ClinicalTrials.gov · Last updated 22 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
90 (actual)
First submitted
12 Jun 2023
Start date
Oct 2023
Primary completion date
Oct 2028
Lead sponsor
Centre Hospitalier St Anne
NCT number
NCT05911178

What you commit to

  • Study type: Interventional
  • Participants enrolled: 90
  • From Oct 2023 to the primary completion date, Oct 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Subject with a psychiatric evolutionary and/or poorly checked pathology (left to the judgement of the investigator).
  • Current auto-immune disease
  • Diagnosis or history of other possible etiology of dementia, including but not limited to other neurodegenerative disorders.

Age

  • Known or supposed histories (≤5 years) of severe alcoholism or misuse of drugs

Other

  • 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.
  • Subject presenting contraindications to the 3T MRI
  • 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.
  • Person placed under the protection of justice
  • Patient under guardianship or curatorship

Who the study is looking for

  • 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.
  • 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
  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Lille
Coordinator of this site? Confirm its status
LilleFranceUnknown status
GHU Saint Anne Psychiatrie & Neurosciences
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU de Rouen
Coordinator of this site? Confirm its status
RouenFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.