Actively Recruiting
Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease
Led by Centre Hospitalier St Anne · Updated on 2024-06-13
90
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier St Anne
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Microglial Activation on Synaptic Density in Alzheimer's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Women able to conceive must use effective contraception
- Signed informed consent
- No general or systemic disorders affecting cognition
- For Alzheimer's patients: progressive amnestic syndrome with or without other cognitive impairments
- Clinical Dementia Rating (CDR) score of 0.5 or 1
- No brain lesions seen on MRI done as part of usual care
- Cerebrospinal fluid biomarkers consistent with Alzheimer's disease
- For controls: no subjective memory problems and normal Mini-Mental State Examination (MMSE) scores (>27 with no more than one word missing)
- Controls aged over 50 years
- Controls have Free and Cued Selective Reminding Test (FCSRT) scores >25 for free recall and >44 total recall
- Controls without general or systemic disorders affecting cognition at follow-up
- Controls matched to Alzheimer's patients by age and education level
You will not qualify if you...
- Psychiatric disorders that are evolving or poorly controlled
- Severe, unstable, or serious medical conditions interfering with study evaluations
- Current autoimmune disease
- Contraindications to 3T MRI
- History (within last 5 years) of severe alcoholism or drug misuse
- Vascular, inflammatory, or mass lesions seen on MRI that interfere with diagnosis
- No health insurance
- Pregnant or breastfeeding women or planning pregnancy within two years
- Diagnosis or history of other causes of dementia or neurodegenerative diseases
- Person under legal protection
- Patients under guardianship or curatorship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
CHU de Lille
Lille, France
Not Yet Recruiting
2
GHU Saint Anne Psychiatrie & Neurosciences
Paris, France
Actively Recruiting
3
CHU de Rouen
Rouen, France
Not Yet Recruiting
Research Team
K
Khaoussou SYLLA, MD, PhD
CONTACT
V
Viviane Awassi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SCREENING
Number of Arms
3
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