New Imaging Biomarkers Predictive of MA Progression
- Conditions
- Progression of DiseaseMR BiomarkersUltra High Field 7TMagnetic Resonance SpectroscopyAlzheimer Disease
- Interventions
- Other: MRI follow-up
- Registration Number
- NCT05939362
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
The pathophysiology of AD is complex. In addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. Several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death.
Ultra-high field imaging (7T MRI) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of Alzheimer's disease. A Magnetic Resonance Spectroscopy (MRS) examination can be coupled to brain MRI without additional risk for the patient. Multinuclear 1H-31P metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of AD. Thus, we propose a longitudinal study in patients with early-stage AD on 7T MRI-MRS.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
-
French-speaking patients aged 60 to 90 years,
-
Patient in the context of Alzheimer's disease * for which imaging after MRI is prescribed as part of the usual diagnostic process,
*Alzheimer's disease is diagnosed by the doctor of the memory consultation and is defined by :Evidence of a storage disorder in verbal episodic memory at LR/RI defined by a sum of LR < 17/48 and sum of RT < 40/48 +/- Impairment of executive functions possible (BREF, TMT grefex, verbal fluencies) +/- Impairment of instrumental functions possible (Grémots noun naming, Rey's figure, Mahieux's Battery).
-
MMSE score ≥18,
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Written informed consent after the patient has been informed,
-
Progressive decline for at least 6 months.
--Partially or completely illiterate patient unable to read and write,
- Patient with an absolute contraindication to 7T MRI
- Severe psychiatric pathology not balanced,
- Non-degenerative neurological disease (stroke, multiple sclerosis ...),
- Patient with tumor or inflammatory pathology, or vascular leukopathy visualized in MRI (Fazekas score > 3)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patient with early onset Alzheimer's disease MRI follow-up -
- Primary Outcome Measures
Name Time Method To identify Magnetic Resonance Imaging biomarkers concentration (mmol/l) at baseline that are predictive of disability progression in individuals with Mild Alzheimer's disease as assessed by the Clinical Dementia Rating (CDR) scale Baseline CDR scale :
No dementia (CDR = 0), Uncertain disorders (CDR = 0.5), Mild disorders (CDR = 1), Moderate disorders (CDR = 2), Severe disorders (CDR = 3).
- Secondary Outcome Measures
Name Time Method Correlation between Imaging biomarkers concentration (mmol/l) and Urinary metabolic parameters (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12). up of 12 months Correlation between Imaging biomarkers concentration (mmol/l) and plasma metabolic parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12). up of 12 months Correlation between Imaging biomarkers concentration (mmol/l) and Enzymatic and protein parameters concentration (mmol/l) at baseline, Month 6 (M6) and Month 12 (M12). up of 12 months Develop realistic mathematical models that integrate multiple parameters from all generated data to predict the progression of Alzheimer's disease, as evaluated using the Clinical Dementia Rating (CDR) up of 12 months Build an Artificial Intelligence (AI) algorithm to predict disability progression in individuals with Mild Alzheimer's disease, as assessed by the Clinical Dementia Rating scale up of 12 months
Trial Locations
- Locations (1)
Chu Poitiers
🇫🇷Poitiers, France