Actively Recruiting
Mechanisms of Neuronal Resilience in Alzheimer's Disease and Its Focal Variants Using PET/MR Imaging
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2024-07-30
45
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
F
France Alzheimer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying mechanisms of neuronal resilience in patients with Alzheimer's disease who have early onset symptoms before 65 years old, as well as in those with a focal form called posterior cortical atrophy (PCA). These patients show different cognitive and brain damage patterns despite having similar pathological features like amyloid and tau protein deposits. The study aims to understand why some patients show resistance to brain degeneration through brain network reorganization and resilience, which is important for improving disease management and future treatments. The study includes three groups: 15 patients with early-onset Alzheimer's disease (AD-Y), 15 patients with PCA, and 15 healthy control participants. All participants will undergo a combined PET/MRI scan session lasting about 3 hours. This imaging includes a 30-minute PET scan with an injected tracer and various MRI sequences to assess brain structure, function, and pathology simultaneously. The study is non-randomized and observational in terms of group assignment. During the study, participants will have brain imaging to highlight resilient neural networks and quantify brain impairment related to Alzheimer's disease within three months. Researchers will also analyze cerebrospinal fluid to correlate tau protein levels with brain lesions and develop models linking brain structural changes to functional alterations. The study monitors participants closely for safety and aims to clarify brain mechanisms underlying resilience to neurodegeneration, which could guide future therapies.
CONDITIONS
Brief Title
MECHANISMS OF NEURONAL RESILIENCE IN ALZHEIMER'S DISEASE AND ITS FOCAL VARIANTS: A PET/MR STUDY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Affiliation to a social security insurance or beneficiary
- Signed informed consent by participant or legal representative
- Age between 40 and 80 years
- For early-onset Alzheimer's group: in vivo proof of Alzheimer's pathology by cerebrospinal fluid analysis or positive PET-amyloid imaging
- Early-onset episodic memory deficit with evidence of hippocampal amnesic syndrome
- For posterior cortical atrophy group: clinical and cognitive profile suggestive of PCA with in vivo proof of Alzheimer's pathology
- Specific neuro-visual impairments without major memory or executive function disorders
- Control subjects with normal neurological and neuropsychological exams matched in age to patients
You will not qualify if you...
- History or risk of torsade de pointe or treatment with drugs that lengthen QT interval
- Contraindications to radiopharmaceutical injection such as renal or hepatic insufficiency or hypersensitivity
- Inability to provide informed consent
- Legal restrictions such as deprivation of liberty or lack of social coverage
- Participation in other therapeutic research or exclusion periods
- Contraindications to MRI including pacemaker, cardiac defibrillator, certain implants, or claustrophobia
- Pregnancy or positive pregnancy test at inclusion
- Symptoms or lab values suggesting systemic disorders that could affect test results or participant health
- Legal protection status
- Sudden cognitive deficits, gait disturbances, convulsions, major behavior changes, or focal neurological signs for AD-Y and PCA groups
- Psychiatric, cerebrovascular, metabolic, or inflammatory diseases
- Pathological neurological exams, history of neurological or psychiatric diseases requiring ongoing drug treatment in control subjects
- Serious physical conditions interfering with cognitive function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a combined PET/MRI examination to assess neural mechanisms and disease characteristics.
1 visit lasting about 3 hours (in-person)
Duration - Up to 3 months
Participants are observed over up to 3 months to measure brain function and disease progression through imaging and assessments.
Visit schedule not specified
Trial Site Locations
Total: 2 locations
1
Service Hospitalier Frédéric Joliot SHFJ
Orsay, France, 91401 cedex
Actively Recruiting
2
Service de Médecine Nucléaire - Hopital La Pitié Salpetriere
Paris, France, 75013
Actively Recruiting
Research Team
M
Marie Odile Habert, MCU-PH
R
Raffaella Migliaccio, MD, PhD, HDR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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